Last updated on March 2016

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

Please choose location

View all locations

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 »

Horst Neuhaus, MD

Evangelisches Krankenhaus D sseldorf, Medizinische Klinik
Düsseldorf, Germany
  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 »