Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT06617468
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-04
First Post:
2024-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Computer Aided Diagnosis with Explainable Artificial Intelligence for Colon Polyp on Optical Diagnosis and Acceptance of Technology
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003936', 'term': 'Diagnosis, Computer-Assisted'}, {'id': 'D000077321', 'term': 'Deep Learning'}], 'ancestors': [{'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000069550', 'term': 'Machine Learning'}, {'id': 'D001185', 'term': 'Artificial Intelligence'}, {'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D016571', 'term': 'Neural Networks, Computer'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-09-25', 'studyFirstSubmitQcDate': '2024-09-25', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of optical diagnosis', 'timeFrame': 'From baseline test to the follow up test (more than 1 month later from baseline test)', 'description': 'The proportion of cases in which pathological results are consistent with endoscopic estimation of adenoma and hyperplastic polyp'}], 'secondaryOutcomes': [{'measure': 'acceptance of computer-aided diagnosis as a technology', 'timeFrame': 'From baseline test to the follow up test (more than 1 month later from baseline test)', 'description': 'Survey on acceptance and use of technology about computer-aided diagnosis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colon polyp', 'optical diagnosis', 'computer-aided diagnosis'], 'conditions': ['Colon Polyp']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if computer-aided diagnosis with deep learning and computer-aided diagnosis with explainable AI work to optical diagnosis performance and acceptance of technology in endoscopists. The main questions it aims to answer are:\n\nDo computer-aided diagnosis with deep learning and computer-aided diagnosis with explainable AI improve optical diagnosis performance in endoscopists?\n\nDoes experience using deep learning-based computer-assisted diagnosis and explainable AI-based computer-assisted diagnosis improve endoscopists' acceptance of computer-aided diagnosis as a technology?\n\nParticipants will:\n\nConduct a survey on acceptance and use of technology about computer-aided diagnosis.\n\nPerform a test to estimate the pathologic diagnosis on 200 NBI still images without the aid of computer-aided diagnosis.\n\nMore than 1 month later, perform a same test to estimate the pathologic diagnosis on 200 NBI still images with computer-aided diagnosis with deep learning or explainable AI.\n\nConduct a survey on acceptance and use of technology about computer-aided diagnosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endoscopists with colonoscopy experience\n\nExclusion Criteria:\n\n* Who can not perform colonoscopy'}, 'identificationModule': {'nctId': 'NCT06617468', 'briefTitle': 'Effect of the Computer Aided Diagnosis with Explainable Artificial Intelligence for Colon Polyp on Optical Diagnosis and Acceptance of Technology', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of the Computer Aided Diagnosis with Explainable Artificial Intelligence for Colon Polyp on Optical Diagnosis and Acceptance of Technology', 'orgStudyIdInfo': {'id': '2311-049-1482'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'computer-aided diagnosis with explainable AI', 'description': 'Perform a same test to estimate the pathologic diagnosis on 200 NBI still images with computer-aided diagnosis with explainable AI', 'interventionNames': ['Diagnostic Test: computer-aided diagnosis with explainable AI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'computer-aided diagnosis with deep learning', 'description': 'Perform a same test to estimate the pathologic diagnosis on 200 NBI still images with computer-aided diagnosis with deep learning', 'interventionNames': ['Diagnostic Test: computer-aided diagnosis with deep learning']}], 'interventions': [{'name': 'computer-aided diagnosis with explainable AI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Perform a same test to estimate the pathologic diagnosis on 200 NBI still images with computer-aided diagnosis with explainable AI.', 'armGroupLabels': ['computer-aided diagnosis with explainable AI']}, {'name': 'computer-aided diagnosis with deep learning', 'type': 'DIAGNOSTIC_TEST', 'description': 'Perform a same test to estimate the pathologic diagnosis on 200 NBI still images with computer-aided diagnosis with deep Iearning.', 'armGroupLabels': ['computer-aided diagnosis with deep learning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06236', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Healthcare System Gangnam Center, Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Su Jin Chung', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}