Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-27 @ 1:32 AM
Study NCT ID:
NCT03961893
Status:
COMPLETED
Last Update Posted:
2023-06-23
First Post:
2019-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, single-phase, two-stage, randomized phase II study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2019-05-21', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)', 'timeFrame': 'Colonoscopy time', 'description': 'Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections'}], 'secondaryOutcomes': [{'measure': 'Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)', 'timeFrame': 'Colonoscopy time', 'description': 'Rate between the number of advanced adenomas detected by the second examination and the number of advanced adenomas detected by the two inspections'}, {'measure': 'Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female', 'timeFrame': 'Colonoscopy time', 'description': 'Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in male and female'}, {'measure': 'Rate of complications', 'timeFrame': 'Colonoscopy time and 1 month after', 'description': 'Global and for each arm'}, {'measure': 'Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup', 'timeFrame': 'Colonoscopy time', 'description': 'Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections in FIT+ subgroup'}, {'measure': 'Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup', 'timeFrame': 'Colonoscopy time', 'description': 'Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in FIT+ subgroup'}, {'measure': 'G-EYE assistance for endoscope stabilization', 'timeFrame': 'Colonoscopy time', 'description': 'Yes or no'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['colonoscopy', 'g-eye', 'adenomas'], 'conditions': ['Colorectal Adenoma']}, 'descriptionModule': {'briefSummary': 'Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Indication of complete colonoscopy for classic indications (bleeding, abdominal pain, transit disorders) or for family and personal antecedents of adenomas or colorectal cancers with the need for endoscopic control,\n2. FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,\n3. Consent of participation signed,\n4. Affiliation to a social security scheme, or beneficiary of such a scheme.\n\nExclusion Criteria:\n\n1. Non-optimal preparation (boston score \\<7 or segment \\<2),\n2. Adenomatous polyposis, familial or assimilated (juvenile, etc.),\n3. Pregnant or likely to be pregnant (without effective contraception) or breastfeeding,\n4. Patient in emergency or deprived of liberty or placed under the authority of a tutor,\n5. Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.'}, 'identificationModule': {'nctId': 'NCT03961893', 'acronym': 'G-EYE-ADR', 'briefTitle': 'Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas', 'orgStudyIdInfo': {'id': 'G-EYE-ADR-IPC 2016-023'}, 'secondaryIdInfos': [{'id': '2018-A03292-53', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Standard colonoscopy then colonoscopy with G-EYE', 'description': 'Arm A: Standard colonoscopy then colonoscopy with G-EYE', 'interventionNames': ['Device: standard colonoscope first and G-EYE']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: G-EYE colonoscopy then standard colonoscopy', 'description': 'Arm B: G-EYE colonoscopy then standard colonoscopy', 'interventionNames': ['Device: G-EYE first and standard colonoscope']}], 'interventions': [{'name': 'G-EYE first and standard colonoscope', 'type': 'DEVICE', 'description': 'Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy', 'armGroupLabels': ['Arm B: G-EYE colonoscopy then standard colonoscopy']}, {'name': 'standard colonoscope first and G-EYE', 'type': 'DEVICE', 'description': 'Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)', 'armGroupLabels': ['Arm A: Standard colonoscopy then colonoscopy with G-EYE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'state': 'Bouches Du Rhone', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Jean-Philippe RATONE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}