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

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Kenneth Chang, MD

UC Irvine Health
Orange, CA United States
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Santiago Horgan, MD

University of California at San Diego
San Diego, CA United States
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Peter Draganov, MD

University of Florida Medical Center
Gainesville, FL United States
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Jose Nieto, MD

The Borland Groover Clinic
Jacksonville, FL United States
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Glen Lehman, MD

Indiana University
Indianapolis, IN United States
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Ram Chuttani, MD

Beth Israel Deaconess Medical Center
Boston, MA United States
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Barham Abu Dayyeh, MD

Mayo Clinic
Rochester, MN United States
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Stavros Stavropoulos, MD

Winthrop University Hospital
Mineola, NY United States
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Gregory Haber, MD

Lenox Hill Hospital
New York, NY United States
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Kyle Perry, MD

Ohio State University Wexner Medical Center
Columbus, OH United States
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Erik Wilson, MD

University of Texas Health Science Center at Houston
Houston, TX United States
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Karel Caca, MD

Klinikum Ludwigsburg
Ludwigsburg, Germany
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Ralf Kiesslich, MD

HSK, Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, Germany
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Pier Alberto Testoni, MD

Ospedale San Raffaele
Milan, Italy
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Guido Costamagna, MD

Universit Cattolica del Sacro Cuore Policlinico A. Gemelli
Rome, Italy
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Horst Neuhaus, MD

Evangelisches Krankenhaus D sseldorf, Medizinische Klinik
Düsseldorf, Germany
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