Nctid:
NCT06617468
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000004194", "term"=>"Disease"}, {"id"=>"D000011127", "term"=>"Polyps"}, {"id"=>"D000003111", "term"=>"Colonic Polyps"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000020763", "term"=>"Pathological Conditions, Anatomical"}, {"id"=>"D000007417", "term"=>"Intestinal Polyps"}], "browseLeaves"=>[{"id"=>"M14011", "name"=>"Polyps", "asFound"=>"Polyps", "relevance"=>"HIGH"}, {"id"=>"M6339", "name"=>"Colonic Polyps", "asFound"=>"Colon Polyp", "relevance"=>"HIGH"}, {"id"=>"M22519", "name"=>"Pathological Conditions, Anatomical", "relevance"=>"LOW"}, {"id"=>"M10451", "name"=>"Intestinal Polyps", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"T120", "name"=>"Cola", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Herbal and Botanical", "abbrev"=>"HB"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "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"=>"ESTIMATED"}, "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"=>"Korea, Republic of", "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"}}}}
