Medigus Ultrasonic Surgical Endostapler (MUSE) Registry
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Registration Number
- NCT02366169
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of device and procedure related adverse events 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
Name Time Method Procedure Durability 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
Trial Locations
- Locations (16)
University of California at San Diego
🇺🇸San Diego, California, United States
UC Irvine Health
🇺🇸Orange, California, United States
University of Florida Medical Center
🇺🇸Gainesville, Florida, United States
The Borland Groover Clinic
🇺🇸Jacksonville, Florida, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Evangelisches Krankenhaus Düsseldorf, Medizinische Klinik
🇩🇪Düsseldorf, Germany
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Germany
HSK, Dr. Horst Schmidt Kliniken GmbH
🇩🇪Wiesbaden, Germany
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Ospedale San Raffaele
🇮🇹Milan, Italy
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
🇮🇹Rome, Italy
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States