Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-03 @ 3:54 PM
Study NCT ID:
NCT02439502
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EndoChoice's Fuse® Endoscopic System Performance In Routine Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2015-04-16', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of findings (abnormal GI findings, such as polyps and tec.) per diagnostic procedure, using Fuse® system', 'timeFrame': '1 outpatient hospitalization day for subject'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Miscellaneous Gastroenterology and Urology Devices Associated With Adverse Incidents, Not Elsewhere Classified']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.endochoice.com/', 'label': 'Additional information regarding the Fuse® system can be found in the study sponsor website.'}]}, 'descriptionModule': {'briefSummary': 'The intent of this study is to evaluate the performance and usability of Fuse in routine practice. The participants are indicated for upper (gastroscopy) and lower (colonoscopy) gastrointestinal endoscopy procedures. The study is open label, prospective and Post Marketing study.', 'detailedDescription': "The intent of this study is to evaluate the performance and usability of Fuse in routine practice EndoChoice's Fuse system - Fuse is an FDA, CE and AMAR approved Endoscopic system (Gastroscope and Colonoscope).\n\nFuse® system The Fuse system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse system consists of camera heads, endoscopes, video system, light source and other ancillary equipment.\n\nFuse Colonoscopes in conjunction with the FuseBox™ processor are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects.\n\nFuse Gastroscopes in conjunction with the FuseBox™ processor are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects ages 18 at least\n* The subject has been scheduled for routine screening upper or lower endoscopy, diagnostic work up, or endoscopic surveillance.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Subjects who are currently enrolled in another clinical study'}, 'identificationModule': {'nctId': 'NCT02439502', 'acronym': 'Fuse®', 'briefTitle': "EndoChoice's Fuse® Endoscopic System Performance In Routine Practice", 'organization': {'class': 'INDUSTRY', 'fullName': 'EndoChoice Innovation Center, Ltd.'}, 'officialTitle': "Single Center, Prospective, Open Label Post Marketing Study of EndoChoice's Fuse® Endoscopic System Performance In Routine Practice", 'orgStudyIdInfo': {'id': 'CD 1978'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'open label', 'description': 'Upper and Lower digestive tract diagnostic. The Fuse® system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse Colonoscopies are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects and for the upper digestive tract (including the esophagus, stomach, and duodenum).', 'interventionNames': ['Device: Fuse® system']}], 'interventions': [{'name': 'Fuse® system', 'type': 'DEVICE', 'description': 'Fuse® system will be used to perform gastro and endoscopic diagnostic procedures for upper and lower GI tract.', 'armGroupLabels': ['open label']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jacob Dickstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel Medical Center, Haifa, Israel.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EndoChoice Innovation Center, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}