Last updated on February 2018

Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02366169

Contact Investigators or Research Sites near you

Start Over

Kenneth Chang, MD

UC Irvine Health
Orange, CA United States
  Connect »

Santiago Horgan, MD

University of California at San Diego
San Diego, CA United States
  Connect »

Peter Draganov, MD

University of Florida Medical Center
Gainesville, FL United States
  Connect »

Jose Nieto, MD

The Borland Groover Clinic
Jacksonville, FL United States
  Connect »

Glen Lehman, MD

Indiana University
Indianapolis, IN United States
  Connect »

Ram Chuttani, MD

Beth Israel Deaconess Medical Center
Boston, MA United States
  Connect »

Barham Abu Dayyeh, MD

Mayo Clinic
Rochester, MN United States
  Connect »

Stavros Stavropoulos, MD

Winthrop University Hospital
Mineola, NY United States
  Connect »

Gregory Haber, MD

Lenox Hill Hospital
New York, NY United States
  Connect »

Kyle Perry, MD

Ohio State University Wexner Medical Center
Columbus, OH United States
  Connect »

Erik Wilson, MD

University of Texas Health Science Center at Houston
Houston, TX United States
  Connect »

Karel Caca, MD

Klinikum Ludwigsburg
Ludwigsburg, Germany
  Connect »

Ralf Kiesslich, MD

HSK, Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, Germany
  Connect »

Pier Alberto Testoni, MD

Ospedale San Raffaele
Milan, Italy
  Connect »

Guido Costamagna, MD

Universit Cattolica del Sacro Cuore Policlinico A. Gemelli
Rome, Italy
  Connect »

Horst Neuhaus, MD

Evangelisches Krankenhaus D sseldorf, Medizinische Klinik
Düsseldorf, Germany
  Connect »

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.