Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-30 @ 8:45 PM
Study NCT ID:
NCT05178095
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2021-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Intelligence in Colonic Polyp Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-12-15', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADR', 'timeFrame': '1 hour', 'description': 'Adenoma detection rate'}], 'secondaryOutcomes': [{'measure': 'APC', 'timeFrame': '1 hour', 'description': 'Adenomas per colonoscopy'}, {'measure': 'Procedural time', 'timeFrame': '1 hour', 'description': 'The number of minutes required to complete the colonoscopy withdrawal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'artificial intelligence'], 'conditions': ['Polyp of Colon', 'Adenoma Colon', 'Gastrointestinal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '38290758', 'type': 'DERIVED', 'citation': 'Scholer J, Alavanja M, de Lange T, Yamamoto S, Hedenstrom P, Varkey J. Impact of AI-aided colonoscopy in clinical practice: a prospective randomised controlled trial. BMJ Open Gastroenterol. 2024 Jan 30;11(1):e001247. doi: 10.1136/bmjgast-2023-001247.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients without IBD referred for colonoscopy\n\nExclusion Criteria:\n\n* Age \\< 40 years\n* Not willing to participate'}, 'identificationModule': {'nctId': 'NCT05178095', 'briefTitle': 'Artificial Intelligence in Colonic Polyp Detection', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Artificial Intelligence in Colonic Polyp Detection', 'orgStudyIdInfo': {'id': 'Dnr 2020-01951'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI', 'description': 'Colonoscopy with AI', 'interventionNames': ['Device: Artificial intelligence']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No AI', 'description': 'Colonoscopy without AI', 'interventionNames': ['Device: No Artificial Intelligence']}], 'interventions': [{'name': 'Artificial intelligence', 'type': 'DEVICE', 'description': 'Colonoscopy with the aid of artificial intelligence for the detection of colonic polyps', 'armGroupLabels': ['AI']}, {'name': 'No Artificial Intelligence', 'type': 'DEVICE', 'description': 'Colonoscopy without the aid of artificial intelligence for the detection of colonic polyps', 'armGroupLabels': ['No AI']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Dr Per Hedenström', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Björn Lindkvist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Per Hedenström', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}