Gastro-esophageal RefluxNCT03669874

Endoscopic Fundoplication With MUSE System

An observational study of Gastro-esophageal Reflux and Endoscopic Fundoplication, run by IRCCS San Raffaele at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Gastro-esophageal Reflux, Endoscopic Fundoplication
What is being tested?: Endoscopic fundoplication
Type of treatment: Medical device
How many people: 80 participants
Where: 1 siteItaly
Study dates: 16 Sep 2015to Sep 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Adult, Older adult

Study population: Patients are selected from tertiary care center

Who may be able to join

Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
Indication to surgical fundoplication
Patients available for a long-term follow-up

Who cannot join

Hiatal hernia ≥ 3 cm
Major esophageal motility disorder
Esophageal stenosis
Malignant neoplasia (except minor superficial skin neoplasm)
Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
Previous cardiac, thoracic or upper GI surgery
BMI >40
Pregnancy or breast feeding

Trial locations and contacts

1 site in 1 country.

Pier Alberto Testoni, Professor contact

+390226432756

testoni.pieralberto@hsr.it

Italy1 site, 1 recruiting

Pier Alberto Testoni
Milan, 20132
Pier Alberto Testoni, MD, 00390226432756
Recruiting

Other trials in Italy

About this study

Official title: Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients

This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives:

Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:
effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores
effect on the use and dosage of proton pump inhibitors (PPI)
feasibility and safety of the endoluminal fundoplication procedure
Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.

The study design includes the following phases:

*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
Yearly clinical follow-up (up to 6 years):

PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

Conditions: Gastro-esophageal Reflux, Endoscopic Fundoplication
Being tested: Endoscopic fundoplication
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endoscopic fundoplicationDevice
Endoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication.
The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the correct tissue thickness for stapling the fundus against the esophagus. The device must be extracted to be reloaded with 5 more staples at a time for creation of a 180° anterior fundoplication.

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
Measured: change from baseline GERD-HRQL at 6 months
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
Measured: change from baseline GERD-HRQL at 12 months
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
Measured: change from baseline GERD-HRQL at 24 months
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
Measured: change from baseline GERD-HRQL at 3 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
Measured: change from baseline GERD-HRQL at 4 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
Measured: change from baseline GERD-HRQL at 5 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
Measured: change from baseline GERD-HRQL at 6 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
Measured: change from baseline RSI at 6 months
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
Measured: change from baseline RSI at 12 months
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
Measured: change from baseline RSI at 24 months
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
Measured: change from baseline RSI at 3 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
Measured: change from baseline RSI at 4 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
Measured: change from baseline RSI at 5 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
Measured: change from baseline RSI at 6 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
Measured: change from baseline PPI consumption at 6 months
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
Measured: change from baseline PPI consumption at 12 months
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
Measured: change from baseline PPI consumption at 24 months
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
Measured: change from baseline PPI consumption at 3 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
Measured: change from baseline PPI consumption at 4 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
Measured: change from baseline PPI consumption at 5 years
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
Measured: change from baseline PPI consumption at 6 years

Secondary outcomes (48)

To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
Measured: change from baseline hiatal hernia size at 6 months
To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
Measured: change from baseline hiatal hernia size at 12 months
To identify endoscopic factors predicting positive outcomes: changes in Hill's grade
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
Measured: change from baseline Hill's grade at 6 months
To identify endoscopic factors predicting positive outcomes: changes in Hill's grade
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
Measured: change from baseline Hill's grade at 12 months
To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
Measured: change from baseline Jobe's lenght at 6 months
To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
Measured: change from baseline Jobe's lenght at 12 months
To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.
Measured: change from baseline esophagitis' grade at 6 months
To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.
Measured: change from baseline esophagitis' grade at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.
Measured: change from baseline DeMeester score at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.
Measured: change from baseline DeMeester score at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline AET at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline AET at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline longest reflux episode at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline longest reflux episode at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of refluxes greater than 5 minutes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of refluxes greater than 5 minutes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of total refluxes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of total refluxes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of acid refluxes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of acid refluxes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of weakly acid refluxes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of weakly acid refluxes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of not acid refluxes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of not acid refluxes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of proximal refluxes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline number of proximal refluxes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline MNBI at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline MNBI at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline PSPW at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline PSPW at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline BCT at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
Measured: change from baseline BCT at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline LES basal pressure at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline LES basal pressure at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline LES lenght at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline LES lenght at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline LES IRP at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline LES IRP at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline DCI at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline DCI at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline rate of peristaltic waves at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline rate of peristaltic waves at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline rate of weak waves at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline rate of weak waves at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline rate of fragmented waves at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline rate of fragmented waves at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline rate of failed waves at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Measured: change from baseline rate of failed waves at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 2015Sep 2026

First posted13 Sep 2018
Study start16 Sep 2015
Primary completion16 Sep 2021 (estimated)
Study completionSep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gastro-esophageal RefluxStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03669874
Sponsor's protocol ID: MUSE/2015
Status last verified: Dec 2020
First submitted: 30 Aug 2018
Last updated: 11 Dec 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Testoni SGG, Cilona MB, Mazzoleni G, Fanti L, Ribichini E, Cavestro GM, Esposito D, Viale E, Notaristefano C, Zuppardo RA, Azzolini F, Passaretti S, Testoni PA. Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years. Surg Endosc. 2022 Jul;36(7):5023-5031. doi: 10.1007/s00464-021-08860-w. Epub 2021 Nov 19.
PubMed 34799745
Testoni PA, Testoni S, Mazzoleni G, Pantaleo G, Cilona MB, Distefano G, Fanti L, Antonelli M, Passaretti S. Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes. Endoscopy. 2020 Jun;52(6):469-473. doi: 10.1055/a-1124-3187. Epub 2020 Mar 18.
PubMed 32187630

Want to know more?

Pier Alberto Testoni, Professor

+390226432756

testoni.pieralberto@hsr.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Enrolling by invitationObservational study
Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
Gastro Esophageal Reflux
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes

All Gastro-esophageal Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients
ClinicalTrials.gov ID: NCT03669874
Acronym / sponsor ID: MUSE/2015
Conditions: Gastro-esophageal Reflux, Endoscopic Fundoplication
Study type: Observational
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: IRCCS San RaffaeleUniversity, hospital or other
Study start: 16 Sep 2015 (actual)
Primary completion: 16 Sep 2021 (estimated)
Study completion: Sep 2026 (estimated)
First posted: 13 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:
effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores
effect on the use and dosage of proton pump inhibitors (PPI)
feasibility and safety of the endoluminal fundoplication procedure
Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.

The study design includes the following phases:

6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
Yearly clinical follow-up (up to 6 years):

PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 70 years
Sex: All
Age groups: Adult, Older adult
Study population: Patients are selected from tertiary care center

Key inclusion criteria (4 listed)

Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
Indication to surgical fundoplication
Patients available for a long-term follow-up

Key exclusion criteria (8 listed)

Hiatal hernia ≥ 3 cm
Major esophageal motility disorder
Esophageal stenosis
Malignant neoplasia (except minor superficial skin neoplasm)
Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endoscopic fundoplicationEndoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication. The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the correct tissue thickness for stapling the fundus against the esophagus. The device must be extracted to be reloaded with 5 more staples at a time for creation of a 180° anterior fundoplication.	Device	–

Primary outcome

To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 6 months
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 12 months
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 24 months
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 3 years
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 4 years
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 5 years
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time frame: change from baseline GERD-HRQL at 6 years
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 6 months
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 12 months
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 24 months
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 3 years
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 4 years
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 5 years
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time frame: change from baseline RSI at 6 years
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 6 months
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 12 months
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 24 months
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 3 years
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 4 years
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 5 years
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time frame: change from baseline PPI consumption at 6 years
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy

48 secondary outcomes

To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size
Time frame: change from baseline hiatal hernia size at 6 months
To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size
Time frame: change from baseline hiatal hernia size at 12 months
To identify endoscopic factors predicting positive outcomes: changes in Hill's grade
Time frame: change from baseline Hill's grade at 6 months
To identify endoscopic factors predicting positive outcomes: changes in Hill's grade
Time frame: change from baseline Hill's grade at 12 months
To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght
Time frame: change from baseline Jobe's lenght at 6 months
To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght
Time frame: change from baseline Jobe's lenght at 12 months
To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade
Time frame: change from baseline esophagitis' grade at 6 months
To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade
Time frame: change from baseline esophagitis' grade at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score
Time frame: change from baseline DeMeester score at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score
Time frame: change from baseline DeMeester score at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)
Time frame: change from baseline AET at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)
Time frame: change from baseline AET at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)
Time frame: change from baseline longest reflux episode at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)
Time frame: change from baseline longest reflux episode at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes
Time frame: change from baseline number of refluxes greater than 5 minutes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes
Time frame: change from baseline number of refluxes greater than 5 minutes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes
Time frame: change from baseline number of total refluxes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes
Time frame: change from baseline number of total refluxes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes
Time frame: change from baseline number of acid refluxes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes
Time frame: change from baseline number of acid refluxes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes
Time frame: change from baseline number of weakly acid refluxes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes
Time frame: change from baseline number of weakly acid refluxes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes
Time frame: change from baseline number of not acid refluxes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes
Time frame: change from baseline number of not acid refluxes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes
Time frame: change from baseline number of proximal refluxes at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes
Time frame: change from baseline number of proximal refluxes at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)
Time frame: change from baseline MNBI at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)
Time frame: change from baseline MNBI at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)
Time frame: change from baseline PSPW at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)
Time frame: change from baseline PSPW at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)
Time frame: change from baseline BCT at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)
Time frame: change from baseline BCT at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure
Time frame: change from baseline LES basal pressure at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure
Time frame: change from baseline LES basal pressure at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght
Time frame: change from baseline LES lenght at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght
Time frame: change from baseline LES lenght at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)
Time frame: change from baseline LES IRP at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)
Time frame: change from baseline LES IRP at 12 months
To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)
Time frame: change from baseline DCI at 6 months
To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)
Time frame: change from baseline DCI at 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
Derived from this study: PubMed 34799745Testoni SGG, Cilona MB, Mazzoleni G, Fanti L, Ribichini E, Cavestro GM, Esposito D, Viale E, Notaristefano C, Zuppardo RA, Azzolini F, Passaretti S, Testoni PA. Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years. Surg Endosc. 2022 Jul;36(7):5023-5031. doi: 10.1007/s00464-021-08860-w. Epub 2021 Nov 19.
Derived from this study: PubMed 32187630Testoni PA, Testoni S, Mazzoleni G, Pantaleo G, Cilona MB, Distefano G, Fanti L, Antonelli M, Passaretti S. Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes. Endoscopy. 2020 Jun;52(6):469-473. doi: 10.1055/a-1124-3187. Epub 2020 Mar 18.

Related trials for Gastro-esophageal Reflux

Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Enrolling by invitationObservational study
Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
Gastro Esophageal Reflux
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pier Alberto Testoni, Professor contact

+390226432756

testoni.pieralberto@hsr.it

Pier Alberto Testoni, Professor principal investigator

San Raffaele Scientific Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Gastro-esophageal Reflux and Endoscopic Fundoplication, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pier Alberto Testoni, Professor (+390226432756, testoni.pieralberto@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score (time frame: change from baseline GERD-HRQL at 6 months). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03669874, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.