Clinical trials: Endoscopic Fundoplication
Gastro Esophageal Reflux
Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and…
- Trial name
- TIF/2021 (NCT05066594)
- Testing
- Transoral incisionless fundoplication
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS San Raffaele
Gastro -Oesophagal Reflux, Laryngo-pharyngeal Reflux
European TIF2.0 Registry
This is a European, multi-centre, prospective registry that aims to determine the safety and efficacy of transoral incisionless fundoplication, with or without concomitant hiatal hernia repair, for the treatment of patients with…
- Trial name
- EURO-TIF (NCT07395219)
- Testing
- Transoral incisionless fundoplication with or without concomitant hiatal hernia repair with the EsophyX device
- Where
- 7 sites in Austria, Italy and 5 more
- Volunteers
- 500 people
- Sponsor
- Cleveland Clinic London
Gastroesophageal Reflux Disease (GERD), Gastroesophageal Reflux (GER)
Development of Machine Learning Models to Predict Postoperative GERD Symptom Resolution After Laparoscopic Nissen Fundoplication
This study aims to develop machine learning models to predict postoperative gastroesophageal reflux symptom resolution after laparoscopic Nissen fundoplication using Elastic Net regression and synthetic minority oversampling…
- Trial name
- NCT06862037
- Testing
- Laparoscopic Nissen fundoplication
- Where
- South Korea
- Volunteers
- 112 people
- Sponsor
- Korea University Anam Hospital
Gastroesophageal Reflux Disease
Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms in Bariatric Patients
A retrospective and prospective cohort study to compare the effect of completing a Transoral Fundoplication procedure prior to Laparoscopic Sleeve Gastrectomy surgery to Laparoscopic Roux-en-Y Gastric Bypass in bariatric patients…
- Trial name
- NCT05365087
- Testing
- Transoral Fundoplication and Sleeve Gastrectomy, Gastric Bypass
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Lexington Health Incorporated
Achalasia
POEM + F for Achalasia - a Pilot Study
This is a pilot study to investigate the feasibility of performing per-oral endoscopic Myotomy (POEM) with endoscopic fundoplication for patient with achalasia.
- Trial name
- NCT05214443
- Testing
- POEM + F
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Chinese University of Hong Kong
Gastroesophageal Reflux
Treatment Of Gastroesophageal Reflux Disease By Endoscopic Fundoplication, A Placebo-Controlled Study
Aim: To evaluate the therapeutic efficacy of a therapeutic procedure, involving endoscopic suturing, for gastroesophageal reflux disease (GERD) compared to a sham procedure.
- Trial name
- NCT00235677
- Testing
- Endoscopic gastroplication
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- UMC Utrecht
Gastroesophageal Reflux Disease (GERD)
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
- Trial name
- TvP (NCT00857597)
- Testing
- Transoral Incisionless Fundoplication, Proton Pump Inhibitors; active control
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- University of Pittsburgh
Gastroesophageal Reflux
Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels
Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux.
- Trial name
- NCT00852098
- Testing
- Lap Nissen fundoplication with division of short gastric vessels, Laparoscopic Nissen fundoplication without division of short gastric vessels
- Where
- 2 sites in Brazil
- Volunteers
- 2 people
- Sponsor
- Federal University of São Paulo
Achalasia Cardia
Randomized Clinical Trial Comparing Short Versus Long Oesophageal Myotomy in POEM for Achalasia Cardia.
Aim of this study is to compare the outcomes of a short esophageal myotomy extending from 3 cm cephalad to the EGJ, to 3 cm distal to it with a long esophageal myotomy with an additional proximal extension (at least 6 cm cephalad…
- Trial name
- NCT03186248
- Testing
- Per oral endoscopic myotomy
- Where
- India
- Volunteers
- 71 people
- Sponsor
- Asian Institute of Gastroenterology, India
Antireflux Mucosal Ablation, Laparoscopic Fundoplication Procedure
Antireflux Mucosal Ablation vs Fundoplication for Refractory GERD
This study compared two treatments for patients with gastroesophageal reflux disease (GERD) that did not improve with standard acid-reducing medications.
- Conditions
- Antireflux Mucosal Ablation, Laparoscopic Fundoplication Procedure, Refractory GERD, Endoscopic Therapy
- Trial name
- NCT07842354
- Testing
- Modified Antireflux Mucosal Ablation (ARMA), Laparoscopic Nissen Fundoplication
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Minia University
Gastroesophageal Reflux Disease (GERD)
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling system for the treatment of GERD. The system allows the operator to staple the stomach to the esophagus,in order to restore the…
- Trial name
- NCT00734747
- Testing
- Medigus SRS endoscopic stapling system
- Where
- 6 sites in United States, Austria and 3 more
- Volunteers
- 72 people
- Sponsor
- Aviel Roy-Shapira, M.D.
Achalasia, Gastroesophageal Reflux Disease
Prospective Collection of Outcome Data Post POEM-TIF Procedure
Per Oral Endoscopic Myotomy has been established as a safe and effective treatment of Achalasia type I and II; however, it is limited by post-procedure gastroesophageal reflux.
- Trial name
- NCT04052581
- Testing
- POEM-TIF
- Sponsor
- Johns Hopkins University
Achalasia
POEM-F for Achalasia International Study
Per-oral endoscopic myotomy (POEM) has emerged as the endoscopic treatment of choice for achalasia, offering comparable symptom relief with laparoscopic Heller's cardiomyotomy.
- Trial name
- NCT06042127
- Testing
- POEM-F, Conventional POEM
- Where
- 7 sites in United States, China and 2 more
- Volunteers
- 81 people
- Sponsor
- Chinese University of Hong Kong
Dysphagia, Achalasia
Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM)
Achalasia is a disorder benign esophageal motor, which is characterized by failure to relax the lower esophageal sphincter ( LES) in response to swallowing associated with lack of peristalsis of the esophageal body.
- Trial name
- NCT02138643
- Testing
- Endoscopic surgery, Laparoscopic surgery
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- University of Sao Paulo General Hospital
Esophageal Achalasia, Esophageal Motility Disorders
POEM Versus Laparoscopic Heller Myotomy With Dor Fundoplication for Esophageal Achalasia
Achalasia is a disorder of the esophagus in which the muscular valve between the esophagus and the stomach fails to relax, and the body of the esophagus loses its normal coordinated squeezing movement.
- Conditions
- Esophageal Achalasia, Esophageal Motility Disorders, Gastroesophageal Reflux
- Trial name
- POEM-HD (NCT07814027)
- Testing
- Peroral endoscopic myotomy, Laparoscopic Heller myotomy with Dor fundoplication
- Where
- Egypt
- Volunteers
- 220 people
- Sponsor
- Minia University
Swallowing Disorders, Achalasia
Transoral Incisionless Fundoplication in Post-POEM GERD
POEM (per oral endoscopic myotomy) is effective for the treatment of swallowing disorders but can induce acid reflux. If acid reflux remains untreated in this situation, it can lead to significant problems.
- Conditions
- Swallowing Disorders, Achalasia, Outlet Obstruction, Gastric, Diffuse Esophageal Spasm
- Trial name
- NCT04770441
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Baylor College of Medicine
Barrett Esophagus, Transoral Incisionless Fundoplication
Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus
Barrett's esophagus (BE) is a precancerous lesion characterized by the replacement of the normal stratified squamous epithelium of the distal esophagus by intestinal metaplasia (IM).
- Trial name
- NCT04457193
- Testing
- TIF
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Johns Hopkins University
Gastroesophageal Reflux Disease
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
The aims of this study are to create a prospective data base to evaluate the long term outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to measure standard outcomes as well as patient derived…
- Trial name
- NCT00260572
- Testing
- Questionnaires to evaluate QOL, Questionnaires to evaluate heartburn and quality of life, Questionnaire to evaluate satisfaction with treatment
- Where
- United States
- Volunteers
- 2,500 people
- Sponsor
- University of Pittsburgh
Gastro Esophageal Reflux
Endoscopic Classification of Fundoplication Integrity Predicts Pathologic Reflux
This single-center, two-phase cohort study aimed to develop and validate a simple endoscopic classification of fundoplication integrity after anti-reflux surgery (ARS - Nissen or Toupet fundoplication).
- Trial name
- NCT07722663
- Where
- Italy
- Volunteers
- 153 people
- Sponsor
- IRCCS Policlinico S. Donato
Gastro-esophageal Reflux, Endoscopic Fundoplication
Endoscopic Fundoplication With MUSE System
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…
- Trial name
- NCT03669874
- Testing
- Endoscopic fundoplication
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- IRCCS San Raffaele