Gastroesophageal Reflux Disease (GERD)
Conditions
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.
Interventions
DEVICEMedigus 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.
Sponsors
Medigus Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany, Italy, United States
Contacts
Primary ContactMelina Salerno
Outcome results
None listed