Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02366169
• Other study ID #: 14-001
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2015
• Last updated: March 31, 2016
• Start date: March 2015
• Est. completion date: December 2019

Study information

• Verified date: March 2016
• Source: MediGus Ltd
• Contact: Melina Salerno
• Email: melina.salerno[@]medigus.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Device:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MediGus Ltd

Countries where clinical trial is conducted

United States,  Germany,  Italy, 

References & Publications (3)

Kim HJ, Kwon CI, Kessler WR, Selzer DJ, McNulty G, Bapaye A, Bonavina L, Lehman GA. Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device. Surg Endosc. 2015 Nov 4. [Epub ahead of print] — View Citation

Roy-Shapira A, Bapaye A, Date S, Pujari R, Dorwat S. Trans-oral anterior fundoplication: 5-year follow-up of pilot study. Surg Endosc. 2015 Dec;29(12):3717-21. doi: 10.1007/s00464-015-4142-9. Epub 2015 Mar 18. — View Citation

Zacherl J, Roy-Shapira A, Bonavina L, Bapaye A, Kiesslich R, Schoppmann SF, Kessler WR, Selzer DJ, Broderick RC, Lehman GA, Horgan S. Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial. Surg Endosc. 2015 Jan;29(1):220-9. doi: 10.1007/s00464-014-3731-3. Epub 2014 Aug 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of device and procedure related adverse events	Device or procedure-related adverse events and serious adverse events will be evaluated for onset, frequency and duration. The primary safety assessment time point will be within 30 days of the procedure.	30 days post procedure	Yes
Secondary	Procedure Durability	Baseline and follow-up measurements of proton pump inhibitors use and GERD Health Related Quality of Life questionnaire will determine the proportion of patients with treatment success	Up to 3 years post procedure	No

External Links

•   Study sponsor website