Medigus Ultrasonic Surgical Endostapler (MUSE) Registry
NCT ID: NCT02366169
Last Updated: 2016-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2015-03-31
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Medigus Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ralf Kiesslich, MD
Role: PRINCIPAL_INVESTIGATOR
Director Klinik für Innere Medizin II; Dr. Horst Schmidt Klinik
Locations
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UC Irvine Health
Orange, California, United States
University of California at San Diego
San Diego, California, United States
University of Florida Medical Center
Gainesville, Florida, United States
The Borland Groover Clinic
Jacksonville, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Winthrop University Hospital
Mineola, New York, United States
Lenox Hill Hospital
New York, New York, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Evangelisches Krankenhaus Düsseldorf, Medizinische Klinik
Düsseldorf, , Germany
Klinikum Ludwigsburg
Ludwigsburg, , Germany
HSK, Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, , Germany
Ospedale San Raffaele
Milan, , Italy
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Gail McNulty, RN
Role: primary
References
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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.
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.
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.
Related Links
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Study sponsor website
Other Identifiers
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14-001
Identifier Type: -
Identifier Source: org_study_id
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