Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

March 31, 2016 updated by: Medigus Ltd

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany
        • Recruiting
        • Evangelisches Krankenhaus Düsseldorf, Medizinische Klinik
        • Contact:
        • Principal Investigator:
          • Horst Neuhaus, MD
      • Ludwigsburg, Germany
        • Recruiting
        • Klinikum Ludwigsburg
        • Contact:
        • Principal Investigator:
          • Karel Caca, MD
      • Wiesbaden, Germany
        • Recruiting
        • HSK, Dr. Horst Schmidt Kliniken GmbH
        • Principal Investigator:
          • Ralf Kiesslich, MD
  • Italy
      • Milan, Italy
        • Recruiting
        • Ospedale San Raffaele
        • Contact:
        • Principal Investigator:
          • Pier Alberto Testoni, MD
      • Rome, Italy, 00168
        • Recruiting
        • Università Cattolica del Sacro Cuore Policlinico A. Gemelli
        • Principal Investigator:
          • Guido Costamagna, MD
        • Contact:
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health
        • Contact:
          • Yuna Muyshondt, MPH
          • Phone Number: 714-456-2215
          • Email: chuny@uci.edu
        • Principal Investigator:
          • Kenneth Chang, MD
      • San Diego, California, United States, 92013
        • Recruiting
        • University of California at San Diego
        • Principal Investigator:
          • Santiago Horgan, MD
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Medical Center
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • The Borland Groover Clinic
        • Contact:
        • Principal Investigator:
          • Ali Lankarani, MD
        • Principal Investigator:
          • Jose Nieto, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
          • Gail McNulty, RN
          • Phone Number: 317-948-3684
        • Principal Investigator:
          • Glen Lehman, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Ram Chuttani, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Barham Abu Dayyeh, MD
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Winthrop University Hospital
        • Contact:
        • Principal Investigator:
          • Stavros Stavropoulos, MD
      • New York, New York, United States, 10021
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
        • Sub-Investigator:
          • Anthony Starpoli, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Wexner Medical Center
        • Contact:
        • Principal Investigator:
          • Kyle Perry, MD
    • Texas
      • Houston, Texas, United States, 77401
        • Recruiting
        • University of Texas Health Science Center at Houston
        • Contact:
        • Principal Investigator:
          • Shinil Shah, MD
        • Sub-Investigator:
          • Kulvinder Bajwa, MD
        • Sub-Investigator:
          • Peter Walker, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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)

Exclusion Criteria:

  • 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
  • Gastric outlet obstruction
  • Short esophagus
  • Esophageal diverticula, strictures or varices
  • Esophageal motility disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of device and procedure related adverse events
Time Frame: 30 days post procedure
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.
30 days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Durability
Time Frame: Up to 3 years post procedure
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
Up to 3 years post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medigus Ltd

Investigators

  • Principal Investigator: Ralf Kiesslich, MD, Director Klinik für Innere Medizin II; Dr. Horst Schmidt Klinik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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