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Gastroesophageal Reflux Disease (GERD)NCT02366169

Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

An observational study of Gastroesophageal Reflux Disease (GERD), run by Medigus Ltd at 16 sites in 3 countries.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This registry is intended as an observational, post-marketing surveillance tool. The registry allows collection of baseline demographics and user experience of the commercially available MUSE system. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastroesophageal Reflux Disease (GERD)
What is being tested?
Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure
Type of treatment
Medical device
How many people
200 participants
Where
16 sitesin 3 countries
Study dates
Mar 2015to Dec 2019
How long will I take part?
3 Years
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
  • No healthy volunteers
  • Adult, Older adult

Study population: The registry population will consist of adult subjects diagnosed with GERD who are deemed suitable for the procedure by the investigator given the information provided in the instructions for use.

Who may be able to join

  • Generally follow the guidelines for Laparoscopic Fundoplication published by SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Objective evidence of GERD
  • Positive acid exposure test or endoscopic evidence of esophagitis AND
  • Inadequate symptom control or
  • Patient preference from surgery over medications or
  • Extra-esophageal manifestations (asthma, hoarseness, cough, chest pain, aspiration)

Who cannot join

  • Significant co-morbidity (for example, American Society of Anesthesiologists Grade 3 or higher)
  • BMI >35 or <20
  • No response to proton pump inhibitors
  • Grade IV esophagitis
  • Hiatal hernia >3 cm
  • Irreducible hernia of any size
Show all 10Show fewer
  • Gastric outlet obstruction
  • Short esophagus
  • Esophageal diverticula, strictures or varices
  • Esophageal motility disorders

Trial locations and contacts

16 sites in 3 countries.

Melina Salerno contact

melina.salerno@medigus.com

16 sites in 3 countries

United States11 sites, 11 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Ram Chuttani, MD, 617-667-0162, vlsheppa@bidmc.harvard.edu

    Ram Chuttani, MD

    Recruiting

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Rebecca Dettorre, Becky.Dettorre@osumc.edu

    Kyle Perry, MD

    Recruiting

  • University of Florida Medical Center

    Gainesville, Florida, 32610

    Peter Draganov, MD, 352-273-9472, peter.draganov@medicine.ufl.edu

    Peter Draganov, MD

    Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77401

    Angielyn Rivera, 713-486-1350, Angielyn.Rivera@uth.tmc.edu

    Shinil Shah, MD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Gail McNulty, RN, 317-948-3684

    Glen Lehman, MD

    Recruiting

  • The Borland Groover Clinic

    Jacksonville, Florida, 32256

    904-680-0871, Research@borlandgrooverclinic.com

    Ali Lankarani, MD

    Recruiting

  • Winthrop University Hospital

    Mineola, New York, 11501

    Maria Kollarus, BSN, RN, 516-663-4652, mkollarus@winthrop.org

    Stavros Stavropoulos, MD

    Recruiting

  • Lenox Hill Hospital

    New York, New York, 10021

    Poi Yu (Sofia) Yuen, MD, 408-384-2038, pyuen2@northwell.edu

    Gregory Haber, MD

    Recruiting

  • UC Irvine Health

    Orange, California, 92868

    Yuna Muyshondt, MPH, 714-456-2215, chuny@uci.edu

    Kenneth Chang, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Janna Mason, 507-266-0516, janna.mason@mayo.edu

    Barham Abu Dayyeh, MD

    Recruiting

  • University of California at San Diego

    San Diego, California, 92013

    Sarah Lazar, MPH, 619-471-0447, misresearch@ucsd.edu

    Santiago Horgan, MD

    Recruiting

Other trials in United States

Germany3 sites, 3 recruiting

  • Evangelisches Krankenhaus Düsseldorf, Medizinische Klinik

    Düsseldorf

    Markus Schneider, MD, 0049-211-919-1605, Markus.Schneider@evk-duesseldorf.de

    Horst Neuhaus, MD

    Recruiting

  • Klinikum Ludwigsburg

    Ludwigsburg

    Karel Caca, MD, 0049 7141 9967201, karel.caca@kliniken-lb.de

    Karel Caca, MD

    Recruiting

  • HSK, Dr. Horst Schmidt Kliniken GmbH

    Wiesbaden

    Ralf Kiesslich, MD

    Recruiting

Other trials in Germany

Italy2 sites, 2 recruiting

  • Ospedale San Raffaele

    Milan

    Sabrina Testoni, 02.2643.2756, pieralberto.testoni@hsr.it

    Pier Alberto Testoni, MD

    Recruiting

  • Università Cattolica del Sacro Cuore Policlinico A. Gemelli

    Rome, 00168

    Carolina Gualtieri, +39 (06) 35511515, c.gualtieri@eetc.it

    Guido Costamagna, MD

    Recruiting

Other trials in Italy

About this study

Official title: A Worldwide Post-Market Surveillance Registry to Assess the Medigus Ultrasonic Surgical Endostapler (MUSE™) System for the Treatment of GERD

This registry is intended as an observational, post-marketing surveillance tool. The registry allows collection of baseline demographics and user experience of the commercially available MUSE system. Data collection aims to aggregate a minimum of 3 years follow-up on a large number of subjects during use outside the constraints of a prescribed clinical study.

Read the detailed description

The registry evaluates the MUSE System which creates a transoral anterior fundoplication for the treatment of GERD. The system enables the operator to staple the fundus of the stomach to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. The procedure is performed transorally under general anesthesia. The procedural result is anatomically and functionally similar to standard anterior fundoplication (Dor-Thal operation). The staples are standard, 4.8mm titanium surgical staples. Each application of the device fires a quintuplet of staples (5) in three staggered rows. Anti-retching medications at the time of the procedure are essential.

The study population will be primarily adults aged 18-70 years selected by the investigators based on SAGES guidelines for fundoplication and consideration of the indications and contraindications listed in the device Instructions for Use (IFU).

Follow-up data will be collected at 6 months, 1, 2 and 3 years post procedure.

Being tested
Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure
Medical subject headings
Gastroesophageal Reflux

What participants receive

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

  • Medigus Ultrasonic Surgical Endostapler (MUSE) ProcedureDevice

    Also called Stapled anterior fundoplication

    The procedure is performed transorally under general anesthesia. The physicians staples the fundus of the stomach to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. The procedural result is anatomically and functionally similar to standard anterior fundoplication (Dor-Thal operation). The staples are standard, 4.8mm titanium surgical staples. Each application of the device fires a quintuplet of staples (5) in three staggered rows. Anti-retching medications at the time of the procedure are essential.

What is being measured

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

  1. Frequency of device and procedure related adverse events

    Device or procedure-related adverse events and serious adverse events will be evaluated for onset, frequency and duration. The primary safety assessment time point will be within 30 days of the procedure.

    Measured: 30 days post procedure

Secondary outcomes (1)

  1. Procedure Durability

    Baseline and follow-up measurements of proton pump inhibitors use and GERD Health Related Quality of Life questionnaire will determine the proportion of patients with treatment success

    Measured: Up to 3 years post procedure

Timeline

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

  1. First posted19 Feb 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

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
200 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02366169
Sponsor's protocol ID
14-001
Status last verified
Mar 2016
First submitted
11 Feb 2015
Last updated
4 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Zacherl J, Roy-Shapira A, Bonavina L, Bapaye A, Kiesslich R, Schoppmann SF, Kessler WR, Selzer DJ, Broderick RC, Lehman GA, Horgan S. Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial. Surg Endosc. 2015 Jan;29(1):220-9. doi: 10.1007/s00464-014-3731-3. Epub 2014 Aug 19.

    PubMed 25135443

  • Roy-Shapira A, Bapaye A, Date S, Pujari R, Dorwat S. Trans-oral anterior fundoplication: 5-year follow-up of pilot study. Surg Endosc. 2015 Dec;29(12):3717-21. doi: 10.1007/s00464-015-4142-9. Epub 2015 Mar 18.

    PubMed 25783833

  • Kim HJ, Kwon CI, Kessler WR, Selzer DJ, McNulty G, Bapaye A, Bonavina L, Lehman GA. Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE endoscopic stapling device. Surg Endosc. 2016 Aug;30(8):3402-8. doi: 10.1007/s00464-015-4622-y. Epub 2015 Nov 4.

    PubMed 26537905

Questions about this trial

What is this clinical trial studying?

An observational study of Gastroesophageal Reflux Disease (GERD), run by Medigus Ltd at 16 sites in 3 countries.

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 5 inclusion and 10 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 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Germany, 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 Melina Salerno (melina.salerno@medigus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of device and procedure related adverse events (time frame: 30 days post procedure). 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 NCT02366169, which also lists 3 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 4 Apr 2016.

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