[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"optical-biopsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:optical-biopsy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100605106","optical-diagnosis-of-neoplasia-using-artificial-intelligence-100605106",false,"NCT07158203","Optical Diagnosis of Neoplasia Using Artificial Intelligence","Assistance for Optical Diagnosis of Neoplasia Using Artificial Intelligence (FAIR Study)","FAIR","Endoscopists who meet the following inclusion\u002Fexclusion criteria Inclusion criteria\n\n* Endoscopists experienced with more than 100 colonoscopies. Exclusion criteria\n* Endoscopists who are involved in the development of the protocol of the present study.\n\nInclusion and exclusion criteria for the study videos. Inclusion criteria.\n\n* Videos with a duration of 15 seconds including both WL and NBI.\n* Videos with diminutive polyps with confirmed pathology. Exclusion criteria.\n* Videos with no clear image of the polyps.\n* Videos with more than one polyp on-screen.\n* Inflammatory bowel disease\n* Polyposis\n* Hereditary colorectal disease\n* Videos which CADx cannot provide sufficient number of outputs.",true,"ALL","18 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"NA","Computer-aided diagnosis (CADx) for colonoscopy aims to enhance optical diagnosis but often underperforms when used alongside humans due to under-reliance on AI. Psychological interventions like cognitive forcing, such as delaying CADx suggestions, may improve human-AI interaction by fostering critical assessment. However, their impact on patient-important outcomes remains unexplored.\n\nThe investigators will conduct an ex-vivo randomized study with 70 endoscopists assessing 100 polyp videos (≤5 mm) using a CADx tool (GI Genius, Medtronic). Participants will be randomized to either:\n\n* Intervention group: CADx suggestions will be shown in the last 3 seconds of the 15 second polyp video.\n* Control group: CADx suggestions will be shown in real-time throughout the playback of the 15 second polyp video.\n\nThe primary endpoint is sensitivity for high-confidence neoplasia detection, with secondary endpoints assessing endoscopists' reliance on AI.\n\nCADx systems on the market function in various ways, such as real-time, delayed, or on-demand diagnosis. Our study aims to inform users and manufacturers whether cognitive forcing through delayed CADx suggestions enhances human-AI interaction, leading to improved clinical outcomes.",[28,29,30,31,32,33,34,35],"Polyps Colorectal","Colonoscopy","Optical Biopsy","Colorectal Cancer Control and Prevention","Colorectal Cancer Screening","Behavior Change","Psychological Factors","Psychological Intervention",[37,38,39,40,41,42],"behaviour","optical biopsy","colonoscopy","CADx system","colorectal polyps","psychological intervention","NOT_YET_RECRUITING","2025-08-28",{"date":46,"type":47},"2025-09-05","ACTUAL",{"date":49,"type":22},"2025-09",{"date":51,"type":22},"2025-12",{"name":53,"class":54},"Fundacin Biomedica Galicia Sur","OTHER",2]