Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
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* Device: Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 3 years post procedure |