Recruiting

MUSEMedigus Ultrasonic Surgical Endostapler (MUSE) Registry

Sponsor:

Medigus Ltd

Code:

NCT02366169

Conditions

Gastroesophageal Reflux Disease (GERD)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure

Study Details

Brief summary:

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.

Conditions

Gastroesophageal Reflux Disease (GERD)

Study ID

NCT02366169

Start date

Mar, 2015

Status verified date

Mar, 2016

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure

The procedure is performed transorally under general anesthesia. The physicians staples the fundus of the stomach to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. 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.

Primary outcome measure

Frequency of device and procedure related adverse events [ Time Frame: 30 days post procedure ]

Central Contacts and Locations

Central contacts

Melina Salerno

melina.salerno@medigus.com

Locations

UC Irvine Health

Recruiting

Orange, California, United States, 92868

Contacts

Yuna Muyshondt, MPH

714-456-2215 chuny@uci.edu

Principal Investigator:

Kenneth Chang, MD

University of California at San Diego

Recruiting

San Diego, California, United States, 92013

Contacts

Sarah Lazar, MPH

619-471-0447 misresearch@ucsd.edu

Principal Investigator:

Santiago Horgan, MD

University of Florida Medical Center

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Peter Draganov, MD

352-273-9472 peter.draganov@medicine.ufl.edu

Principal Investigator:

Peter Draganov, MD

The Borland Groover Clinic

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

904-680-0871 Research@borlandgrooverclinic.com

Principal Investigator:

Ali Lankarani, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Gail McNulty, RN

317-948-3684

Principal Investigator:

Glen Lehman, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Ram Chuttani, MD

617-667-0162 vlsheppa@bidmc.harvard.edu

Principal Investigator:

Ram Chuttani, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Janna Mason

507-266-0516 janna.mason@mayo.edu

Principal Investigator:

Barham Abu Dayyeh, MD

Winthrop University Hospital

Recruiting

Mineola, New York, United States, 11501

Contacts

Maria Kollarus, BSN, RN

516-663-4652 mkollarus@winthrop.org

Principal Investigator:

Stavros Stavropoulos, MD

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10021

Contacts

Poi Yu (Sofia) Yuen, MD

408-384-2038 pyuen2@northwell.edu

Principal Investigator:

Gregory Haber, MD

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Rebecca Dettorre

Becky.Dettorre@osumc.edu

Principal Investigator:

Kyle Perry, MD

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77401

Contacts

Angielyn Rivera

713-486-1350 Angielyn.Rivera@uth.tmc.edu

Principal Investigator:

Shinil Shah, MD

More Information

Sponsor

Medigus Ltd

Last update posted

Apr 4, 2016

Last verified

Mar, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medigus Ltd on 2016-04-04.