Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-03-21 @ 1:27 PM
Study NCT ID:
NCT02366169
Status:
UNKNOWN
Last Update Posted:
2016-04-04
First Post:
2015-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medigus Ultrasonic Surgical Endostapler (MUSE) Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-31', 'studyFirstSubmitDate': '2015-02-11', 'studyFirstSubmitQcDate': '2015-02-18', 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of device and procedure related adverse events', 'timeFrame': '30 days post procedure', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Procedure Durability', 'timeFrame': 'Up to 3 years post procedure', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease (GERD)']}, 'referencesModule': {'references': [{'pmid': '25135443', 'type': 'BACKGROUND', '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.'}, {'pmid': '25783833', 'type': 'BACKGROUND', '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.'}, {'pmid': '26537905', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.medigus.com', 'label': 'Study sponsor website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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).\n\nFollow-up data will be collected at 6 months, 1, 2 and 3 years post procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGenerally follow the guidelines for Laparoscopic Fundoplication published by SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Objective evidence of GERD\n\n* Positive acid exposure test or endoscopic evidence of esophagitis AND\n* Inadequate symptom control or\n* Patient preference from surgery over medications or\n* Extra-esophageal manifestations (asthma, hoarseness, cough, chest pain, aspiration)\n\nExclusion Criteria:\n\n* Significant co-morbidity (for example, American Society of Anesthesiologists Grade 3 or higher)\n* BMI \\>35 or \\<20\n* No response to proton pump inhibitors\n* Grade IV esophagitis\n* Hiatal hernia \\>3 cm\n* Irreducible hernia of any size\n* Gastric outlet obstruction\n* Short esophagus\n* Esophageal diverticula, strictures or varices\n* Esophageal motility disorders'}, 'identificationModule': {'nctId': 'NCT02366169', 'briefTitle': 'Medigus Ultrasonic Surgical Endostapler (MUSE) Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medigus Ltd'}, 'officialTitle': 'A Worldwide Post-Market Surveillance Registry to Assess the Medigus Ultrasonic Surgical Endostapler (MUSE™) System for the Treatment of GERD', 'orgStudyIdInfo': {'id': '14-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure', 'type': 'DEVICE', 'otherNames': ['Stapled anterior fundoplication'], 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yuna Muyshondt, MPH', 'role': 'CONTACT', 'email': 'chuny@uci.edu', 'phone': '714-456-2215'}, {'name': 'Kenneth Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC Irvine Health', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92013', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Lazar, MPH', 'role': 'CONTACT', 'email': 'misresearch@ucsd.edu', 'phone': '619-471-0447'}, {'name': 'Santiago Horgan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California at San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter Draganov, MD', 'role': 'CONTACT', 'email': 'peter.draganov@medicine.ufl.edu', 'phone': '352-273-9472'}, {'name': 'Peter Draganov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florida Medical Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Research@borlandgrooverclinic.com', 'phone': '904-680-0871'}, {'name': 'Ali Lankarani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jose Nieto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Borland Groover Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gail McNulty, RN', 'role': 'CONTACT', 'phone': '317-948-3684'}, {'name': 'Glen Lehman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ram Chuttani, MD', 'role': 'CONTACT', 'email': 'vlsheppa@bidmc.harvard.edu', 'phone': '617-667-0162'}, {'name': 'Ram Chuttani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janna Mason', 'role': 'CONTACT', 'email': 'janna.mason@mayo.edu', 'phone': '507-266-0516'}, {'name': 'Barham Abu Dayyeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Kollarus, BSN, RN', 'role': 'CONTACT', 'email': 'mkollarus@winthrop.org', 'phone': '516-663-4652'}, {'name': 'Stavros Stavropoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Winthrop University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Poi Yu (Sofia) Yuen, MD', 'role': 'CONTACT', 'email': 'pyuen2@northwell.edu', 'phone': '408-384-2038'}, {'name': 'Gregory Haber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anthony Starpoli, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Dettorre', 'role': 'CONTACT', 'email': 'Becky.Dettorre@osumc.edu'}, {'name': 'Kyle Perry, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77401', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angielyn Rivera', 'role': 'CONTACT', 'email': 'Angielyn.Rivera@uth.tmc.edu', 'phone': '713-486-1350'}, {'name': 'Shinil Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Erik Wilson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kulvinder Bajwa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Peter Walker, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus Schneider, MD', 'role': 'CONTACT', 'email': 'Markus.Schneider@evk-duesseldorf.de', 'phone': '0049-211-919-1605'}, {'name': 'Horst Neuhaus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Evangelisches Krankenhaus Düsseldorf, Medizinische Klinik', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Ludwigsburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karel Caca, MD', 'role': 'CONTACT', 'email': 'karel.caca@kliniken-lb.de', 'phone': '0049 7141 9967201'}, {'name': 'Karel Caca, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Ludwigsburg', 'geoPoint': {'lat': 48.89731, 'lon': 9.19161}}, {'city': 'Wiesbaden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ralf Kiesslich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HSK, Dr. Horst Schmidt Kliniken GmbH', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sabrina Testoni', 'role': 'CONTACT', 'email': 'pieralberto.testoni@hsr.it', 'phone': '02.2643.2756'}, {'name': 'Pier Alberto Testoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00168', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carolina Gualtieri', 'role': 'CONTACT', 'email': 'c.gualtieri@eetc.it', 'phone': '+39 (06) 35511515'}, {'name': 'Guido Costamagna, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università Cattolica del Sacro Cuore Policlinico A. Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Melina Salerno', 'role': 'CONTACT', 'email': 'melina.salerno@medigus.com'}], 'overallOfficials': [{'name': 'Ralf Kiesslich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director Klinik für Innere Medizin II; Dr. Horst Schmidt Klinik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medigus Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}