Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT04708951
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2021-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized to one of two groups - ECV colonoscopy or G-EYE® colonoscopy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 970}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision®', 'timeFrame': 'June 2021', 'description': 'G-EYE® colonoscopy adenoma detection rate will be compared to the adenoma detection rate of EndoCuff Vision® colonoscopy. The primary performance measure is the adenoma detection rate (ADR), which is defined as the percentage of subjects with at least one adenoma found, in each of the study groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Adenoma', 'Colorectal Cancer'], 'conditions': ['Adenoma', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The study is intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.', 'detailedDescription': 'This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Screening and surveillance population for Adenoma and CRC.\n2. The patient must understand and sign a written informed consent for the procedure.\n\nExclusion Criteria:\n\n1. Subjects with inflammatory bowel disease;\n2. Subjects with a personal history of hereditary polyposis syndrome;\n3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;\n4. Subjects with diverticulitis or toxic megacolon;\n5. Subjects with prior colonic surgery (exclusion appendectomy)\n6. Subjects with a history of radiation therapy to abdomen or pelvis;\n7. Pregnant or lactating female subjects;\n8. Subjects who are currently enrolled in another clinical investigation.\n9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.\n10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)\n11. Any patient condition deemed too risky for the study by the investigator'}, 'identificationModule': {'nctId': 'NCT04708951', 'briefTitle': 'Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Horst Schmidt Klinik GmbH'}, 'officialTitle': 'A Prospective Randomized Comparison of Colonoscopy Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®) (Endocuff) Versus a Permanently Mounted Balloon (G-EYE®)', 'orgStudyIdInfo': {'id': 'ENDOCUFF vs. G-EYE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ECV colonoscopy', 'description': 'EndoCuff Vision® device (ECV)', 'interventionNames': ['Device: ENDOCUFF VISION® device']}, {'type': 'EXPERIMENTAL', 'label': 'G-EYE® colonoscopy', 'description': 'G-EYE® colonoscope (G-EYE)', 'interventionNames': ['Device: G-EYE® colonoscope']}], 'interventions': [{'name': 'ENDOCUFF VISION® device', 'type': 'DEVICE', 'description': "ENDOCUFF VISION® is a disposable cap placed on the tip of a standard colonoscope, intended to flatten colonic folds and assist in controlling the colonoscope's field of view and tip positioning", 'armGroupLabels': ['ECV colonoscopy']}, {'name': 'G-EYE® colonoscope', 'type': 'DEVICE', 'description': "The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning", 'armGroupLabels': ['G-EYE® colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '65199', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Helios Dr. Horst Schmidt Kliniken Wiesbaden', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Ralf Kiesslich, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helios Dr. Horst Schmidt Kliniken Wiesbaden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Horst Schmidt Klinik GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Prof. Dr. Ralf Kiesslich', 'investigatorAffiliation': 'Dr. Horst Schmidt Klinik GmbH'}}}}