Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 11:18 AM
Study NCT ID:
NCT05732233
Status:
TERMINATED
Last Update Posted:
2024-05-13
First Post:
2023-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RITUAL Ultivision AI CADe Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Pathologist is blind to group assignment'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel trial design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'whyStopped': 'Business decision to discontinue the study. Discontinuation is not related to any patient safety or performance issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma per Colonoscopy (APC)', 'timeFrame': 'During the procedure/surgery', 'description': 'Superiority of Ultivision-AI arm versus control arm. APC is defined as the total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.'}, {'measure': 'Adenoma Per Extraction (APE).', 'timeFrame': 'During the procedure/surgery', 'description': 'Non inferiority of Ultivision-AI arm versus control arm. Where APE is the fraction of adenoma, sessile serrated lesions, and large (\\>10mm) hyperplastic polyps of the proximal colon (caecum, ascending colon, hepatic flexure, and transverse colon) out of total number of resections.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Screening', 'Surveillance', 'Artificial Intelligence', 'Colonoscopy'], 'conditions': ['Colon Adenoma', 'Polyp of Colon', 'Adenoma Colon']}, 'referencesModule': {'references': [{'pmid': '29928897', 'type': 'RESULT', 'citation': 'Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18.'}], 'seeAlsoLinks': [{'url': 'https://satisfai.health/', 'label': 'Satisfai Health'}, {'url': 'https://www.meditrial.net/', 'label': 'Meditrial Clinical Research Organization'}]}, 'descriptionModule': {'briefSummary': 'Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas).\n\nUltivision AI CADe is indicated for white light colonoscopy only.', 'detailedDescription': "Ultivision AI contains an image processing software and algorithm based on machine learning technology and convolutional neural networks (CNN).\n\nThe algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 45 to 75 years;\n2. Screening or surveillance colonoscopy.\n3. Iinformed consent\n\nExclusion Criteria:\n\n1. Colorectal cancer;\n2. Inflammatory bowel disease, including Crohn's disease or ulcerative colitis;\n3. Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X;\n4. Positive Fecal Immunochemical Test;\n5. Use anti-platelet agents or anticoagulants that prevent polyps removal;\n6. Colon resection, not including the appendix;\n7. Subject is pregnant or lactating."}, 'identificationModule': {'nctId': 'NCT05732233', 'acronym': 'RITUAL', 'briefTitle': 'RITUAL Ultivision AI CADe Randomized Controlled Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Satisfai Health, Inc.'}, 'officialTitle': 'Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy', 'orgStudyIdInfo': {'id': 'STF-2023-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultivision AI colonoscopy (CADe Arm)', 'description': 'Ultivision AI is used to aid in real-time detection of adenomas.', 'interventionNames': ['Device: Ultivision AI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard colonoscopy (Control Arm)', 'description': 'Patients will undergo standard colonoscopy without AI.', 'interventionNames': ['Device: Ultivision AI']}], 'interventions': [{'name': 'Ultivision AI', 'type': 'DEVICE', 'description': 'Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas) in adult patients undergoing colorectal cancer screening and surveillance examinations.', 'armGroupLabels': ['Standard colonoscopy (Control Arm)', 'Ultivision AI colonoscopy (CADe Arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': 'H2X 0A9', 'city': 'Montréal (Québec)', 'state': 'Montreal', 'country': 'Canada', 'facility': 'University of Montreal Research Center (CRCHUM)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Satisfai Health, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Meditrial USA Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}