Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

Status unconfirmed

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

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.

Key facts

Study ID

NCT02366169

Run by

Medigus Ltd

People needed

200

Starts

2015-03-01

Expected to finish

2019-12-01

Last updated by the study team

2016-04-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• UC Irvine Health — Orange, California, United States (enrolling)
• University of California at San Diego — San Diego, California, United States (enrolling)
• University of Florida Medical Center — Gainesville, Florida, United States (enrolling)
• The Borland Groover Clinic — Jacksonville, Florida, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Winthrop University Hospital — Mineola, New York, United States (enrolling)
• Lenox Hill Hospital — New York, New York, United States (enrolling)
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
• Evangelisches Krankenhaus Düsseldorf, Medizinische Klinik — Düsseldorf, Germany (enrolling)
• Klinikum Ludwigsburg — Ludwigsburg, Germany (enrolling)
• HSK, Dr. Horst Schmidt Kliniken GmbH — Wiesbaden, Germany (enrolling)
• Ospedale San Raffaele — Milan, Italy (enrolling)
• Università Cattolica del Sacro Cuore Policlinico A. Gemelli — Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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