Medigus Ultrasonic Surgical Endostapler (MUSE) Registry



Status:Recruiting
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:March 2015
End Date:December 2019
Contact:Melina Salerno
Email:melina.salerno@medigus.com

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

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.

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.

Inclusion Criteria:

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)

Exclusion Criteria:

- 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
We found this trial at
12
sites
Orange, California
Principal Investigator: Kenneth Chang, MD
Phone: 714-456-2215
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Ram Chuttani, MD
Phone: 617-667-0162
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Shinil Shah, MD
Phone: 713-486-1350
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Glen Lehman, MD
Phone: 317-948-3684
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
Principal Investigator: Ali Lankarani, MD
Phone: 904-680-0871
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Jacksonville, FL
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Kyle Perry, MD
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Düsseldorf,
Principal Investigator: Horst Neuhaus, MD
Phone: 0049-211-919-1605
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Düsseldorf,
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Gainesville, Florida 32610
Principal Investigator: Peter Draganov, MD
Phone: 352-273-9472
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Stavros Stavropoulos, MD
Phone: 516-663-4652
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mineola, NY
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New York, New York 10021
Principal Investigator: Gregory Haber, MD
Phone: 408-384-2038
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Rochester, Minnesota 55905
Principal Investigator: Barham Abu Dayyeh, MD
Phone: 507-266-0516
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Rochester, MN
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San Diego, California 92093
Principal Investigator: Santiago Horgan, MD
Phone: 619-471-0447
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San Diego, CA
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