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



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


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.


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


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


  • 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


accepting new patients
Start Date
Completion Date
Medigus Ltd
Study sponsor website
Study Type
Observational [Patient Registry]
Last Updated