Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT05611151
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel trial design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 830}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-08', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenomas per Colonoscopy (APC)', 'timeFrame': 'during the procedure/surgery', 'description': 'Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Screening', 'Artificial Intelligence'], 'conditions': ['Colorectal Cancer', 'Adenoma Colon', 'Polyp of Colon']}, 'referencesModule': {'references': [{'pmid': '31594962', 'type': 'BACKGROUND', 'citation': 'Yamada M, Saito Y, Imaoka H, Saiko M, Yamada S, Kondo H, Takamaru H, Sakamoto T, Sese J, Kuchiba A, Shibata T, Hamamoto R. Development of a real-time endoscopic image diagnosis support system using deep learning technology in colonoscopy. Sci Rep. 2019 Oct 8;9(1):14465. doi: 10.1038/s41598-019-50567-5.'}], 'seeAlsoLinks': [{'url': 'http://meditrial.net', 'label': 'Meditrial Clinical Research Organization'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC).\n\nEligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy :\n\n* Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group)\n* Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)', 'detailedDescription': 'This study aims to evaluate whether NEC WISE VISION® Endoscopy enhances the ability to detect mucosal lesions when compared with the current standard-of-care procedure (high-definition white light \\[HDWL\\] colonoscopy). The CADe device, Wise VISION® Endoscopy, contains an artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists in detection of colonic lesions.\n\nThis study plans to enrol 830 subjects aged ≥ 45 years and \\< 75 years, who are scheduled for screening or surveillance colonoscopy.\n\nAfter review of the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADe Group) or standard colonoscopy without CADe (Standard Colonoscopy Group).\n\nAll adenomas, that are identified during the colonoscopies, will be removed and biopsied as per standard clinical practice to assess adenoma miss rate, polyp miss rate, adenomas per colonoscopy and other endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.\n* Signed Informed Consent\n\nExclusion Criteria:\n\n1. Contraindications to colonoscopy\n2. Colonoscopy within the previous three (3) years\n3. High-risk indications for colonoscopy\n4. Antithrombotic therapy that cannot be stopped, precluding polyp resection\n5. Inflammatory bowel disease\n6. Referred for endoscopic mucosal resection (EMR)\n7. Familial adenomatous polyposis syndrome or Serrated Polyposis Syndrome\n8. Pregnant or planning a pregnancy during the study period'}, 'identificationModule': {'nctId': 'NCT05611151', 'acronym': 'COLOWISE', 'briefTitle': 'Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'NEC Corporation'}, 'officialTitle': 'Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy: Prospective, Randomized Clinical Performance Evaluation', 'orgStudyIdInfo': {'id': 'WV-2022-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CADe Colonoscopy', 'description': 'CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy', 'interventionNames': ['Diagnostic Test: Computer Aided Detection (CADe)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HDWL Colonoscopy', 'description': 'HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe', 'interventionNames': ['Diagnostic Test: Computer Aided Detection (CADe)']}], 'interventions': [{'name': 'Computer Aided Detection (CADe)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract.', 'armGroupLabels': ['CADe Colonoscopy', 'HDWL Colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City VA Hospital', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Bad Salzuflen', 'country': 'Germany', 'facility': 'GastroZentrum Lippe', 'geoPoint': {'lat': 52.0862, 'lon': 8.74434}}, {'city': 'Castellanza', 'country': 'Italy', 'facility': 'Humanitas Mater Domini', 'geoPoint': {'lat': 45.61079, 'lon': 8.89616}}, {'zip': '20089', 'city': 'Milan', 'country': 'Italy', 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals University NHS Trust, Cosham', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}], 'overallOfficials': [{'name': 'Hitoshi Ikeda', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NEC Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NEC Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Meditrial Europe Ltd.', 'class': 'INDUSTRY'}, {'name': 'Meditrial USA Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}