Medigus Ultrasonic Surgical Endostapler (MUSE) Registry
Purpose
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
- Gastroesophageal Reflux Disease (GERD)
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Houston, Texas 77401
More Details
- Status
- Unknown status
- Sponsor
- Medigus Ltd
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.