Clinical trial NCT02366169: Medigus Ultrasonic Surgical Endostapler (MUSE) Registry
Official title: A Worldwide Post-Market Surveillance Registry to Assess the Medigus Ultrasonic Surgical Endostapler (MUSE™) System for the Treatment of GERD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Reflux Disease (GERD)
Lead sponsor: Medigus Ltd
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry population will consist of adult subjects diagnosed with GERD who are deemed suitable for the procedure by the investigator given the information provided in the instructions for use.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of device and procedure related adverse events
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Procedure Durability
timeFrame: Up to 3 years post procedure
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: Gainesville
country: United States
facility: University of Florida Medical Center
state: Florida
city: Jacksonville
country: United States
facility: The Borland Groover Clinic
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf, Medizinische Klinik
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
city: Wiesbaden
country: Germany
facility: HSK, Dr. Horst Schmidt Kliniken GmbH
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore Policlinico A. Gemelli
Study officials:
affiliation: Director Klinik für Innere Medizin II; Dr. Horst Schmidt Klinik
name: Ralf Kiesslich, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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. 2016 Aug;30(8):3402-8. doi: 10.1007/s00464-015-4622-y. Epub 2015 Nov 4.