Summary

for people ages 18-70 (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Santiago Horgan

Description

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.

Official Title

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

Details

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.

Keywords

Gastroesophageal Reflux Disease (GERD) Gastroesophageal Reflux Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure

Eligibility

You can join if…

Open to people ages 18-70

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)

You CAN'T join if...

  • 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

Locations

  • University of California at San Diego accepting new patients
    San Diego California 92013 United States
  • UC Irvine Health accepting new patients
    Orange California 92868 United States

Lead Scientist

  • Santiago Horgan
    Dr. Santiago Horgan is an internationally recognized expert in robot-assisted surgery and other minimally invasive surgical techniques. Dr. Horgan is among the first surgeons trained to perform the Lap-Band Adjustable Gastric Banding System procedure used for the treatment of obesity.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medigus Ltd
Links
Study sponsor website
ID
NCT02366169
Study Type
Observational [Patient Registry]
Last Updated