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Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

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ClinicalTrials.gov Identifier: NCT02366169
Recruitment Status : Recruiting
First Posted : February 19, 2015
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Medigus Ltd

Brief 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. 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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease (GERD) Device: Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Worldwide Post-Market Surveillance Registry to Assess the Medigus Ultrasonic Surgical Endostapler (MUSE™) System for the Treatment of GERD
Study Start Date : March 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil


Intervention Details:
  • Device: Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure
    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.
    Other Name: Stapled anterior fundoplication


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366169


Contacts
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Contact: Melina Salerno melina.salerno@medigus.com

Locations
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United States, California
UC Irvine Health Recruiting
Orange, California, United States, 92868
Contact: Yuna Muyshondt, MPH    714-456-2215    chuny@uci.edu   
Principal Investigator: Kenneth Chang, MD         
University of California at San Diego Recruiting
San Diego, California, United States, 92013
Contact: Sarah Lazar, MPH    619-471-0447    misresearch@ucsd.edu   
Principal Investigator: Santiago Horgan, MD         
United States, Florida
University of Florida Medical Center Recruiting
Gainesville, Florida, United States, 32610
Contact: Peter Draganov, MD    352-273-9472    peter.draganov@medicine.ufl.edu   
Principal Investigator: Peter Draganov, MD         
The Borland Groover Clinic Recruiting
Jacksonville, Florida, United States, 32256
Contact    904-680-0871    Research@borlandgrooverclinic.com   
Principal Investigator: Ali Lankarani, MD         
Principal Investigator: Jose Nieto, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Gail McNulty, RN    317-948-3684      
Principal Investigator: Glen Lehman, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ram Chuttani, MD    617-667-0162    vlsheppa@bidmc.harvard.edu   
Principal Investigator: Ram Chuttani, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Janna Mason    507-266-0516    janna.mason@mayo.edu   
Principal Investigator: Barham Abu Dayyeh, MD         
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Maria Kollarus, BSN, RN    516-663-4652    mkollarus@winthrop.org   
Principal Investigator: Stavros Stavropoulos, MD         
Lenox Hill Hospital Recruiting
New York, New York, United States, 10021
Contact: Poi Yu (Sofia) Yuen, MD    408-384-2038    pyuen2@northwell.edu   
Principal Investigator: Gregory Haber, MD         
Sub-Investigator: Anthony Starpoli, MD         
United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Rebecca Dettorre       Becky.Dettorre@osumc.edu   
Principal Investigator: Kyle Perry, MD         
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77401
Contact: Angielyn Rivera    713-486-1350    Angielyn.Rivera@uth.tmc.edu   
Principal Investigator: Shinil Shah, MD         
Principal Investigator: Erik Wilson, MD         
Sub-Investigator: Kulvinder Bajwa, MD         
Sub-Investigator: Peter Walker, MD         
Germany
Evangelisches Krankenhaus Düsseldorf, Medizinische Klinik Recruiting
Düsseldorf, Germany
Contact: Markus Schneider, MD    0049-211-919-1605    Markus.Schneider@evk-duesseldorf.de   
Principal Investigator: Horst Neuhaus, MD         
Klinikum Ludwigsburg Recruiting
Ludwigsburg, Germany
Contact: Karel Caca, MD    0049 7141 9967201    karel.caca@kliniken-lb.de   
Principal Investigator: Karel Caca, MD         
HSK, Dr. Horst Schmidt Kliniken GmbH Recruiting
Wiesbaden, Germany
Principal Investigator: Ralf Kiesslich, MD         
Italy
Ospedale San Raffaele Recruiting
Milan, Italy
Contact: Sabrina Testoni    02.2643.2756    pieralberto.testoni@hsr.it   
Principal Investigator: Pier Alberto Testoni, MD         
Università Cattolica del Sacro Cuore Policlinico A. Gemelli Recruiting
Rome, Italy, 00168
Contact: Carolina Gualtieri    +39 (06) 35511515    c.gualtieri@eetc.it   
Principal Investigator: Guido Costamagna, MD         
Sponsors and Collaborators
Medigus Ltd
Investigators
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Principal Investigator: Ralf Kiesslich, MD Director Klinik für Innere Medizin II; Dr. Horst Schmidt Klinik