Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:37 AM
Study NCT ID:
NCT05006092
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2021-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)
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': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adenoma detection rate', 'timeFrame': '4 months', 'description': 'proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas'}], 'secondaryOutcomes': [{'measure': 'polyp detection rate', 'timeFrame': '4 months', 'description': 'Exmainations with minimum one polyp detected.'}, {'measure': 'withdrawal time', 'timeFrame': '4 months', 'description': 'Time of withdrawal.'}, {'measure': 'resection time', 'timeFrame': '4 months', 'description': 'Time spent on polyp resections.'}, {'measure': 'Boston Bowl Preparation Score', 'timeFrame': '4 months', 'description': 'minimum 0, Maximum 9; should be higher than 5 for appropriate surveillance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surveillance Endoscopy for Colorectal Cancer', 'Artificial Intelligence', 'Polyps of Colon', 'CADe']}, 'referencesModule': {'references': [{'pmid': '35543874', 'type': 'DERIVED', 'citation': 'Lux TJ, Banck M, Sassmannshausen Z, Troya J, Krenzer A, Fitting D, Sudarevic B, Zoller WG, Puppe F, Meining A, Hann A. Pilot study of a new freely available computer-aided polyp detection system in clinical practice. Int J Colorectal Dis. 2022 Jun;37(6):1349-1354. doi: 10.1007/s00384-022-04178-8. Epub 2022 May 11.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of an artificial intelligence system for polyp detection (CADe)', 'detailedDescription': 'We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication CRC surveillance endoscopy\n* indication post-polypectomy surveillance endoscopy\n* positive fecal immunochemical test in patients \\>=50 years\n\nExclusion Criteria:\n\n* reasonable suspicion of inflammatory bowl disease\n* reasonable suspicion of familiar polyposis Syndrome\n* Patient after radiation/resection of colonic parts'}, 'identificationModule': {'nctId': 'NCT05006092', 'acronym': 'SMARTIE', 'briefTitle': 'Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort', 'orgStudyIdInfo': {'id': 'F-2021-047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surveillance endoscopy with CADe support', 'description': 'Endoscopy perfomed with CADe support.', 'interventionNames': ['Device: ENDOMIND']}, {'type': 'NO_INTERVENTION', 'label': 'conventional surveillance endoscopy', 'description': 'Endoscopy perfomed without CADe support.'}], 'interventions': [{'name': 'ENDOMIND', 'type': 'DEVICE', 'description': 'CADe system for Polyp detection', 'armGroupLabels': ['surveillance endoscopy with CADe support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Alexander Hann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wuerzburg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klinikum Stuttgart', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}