[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605106":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":42,"locations":51,"responsibleParty":83,"collaborators":25,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":25,"enrollmentInfo":96,"targetDuration":25,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":112,"overallStatus":119,"whyStopped":25,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Fundacin Biomedica Galicia Sur","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CADx suggestions will be shown in 15 second polyp video.","ACTIVE_COMPARATOR","CADx suggestions will be shown in real-time throughout the playback of the 15 second polyp video.",[13],"Device: CADx simultaneously",{"label":15,"type":16,"description":15,"interventionNames":17},"CADx suggestions will be shown in the last 3 seconds of the 15 second polyp video.","EXPERIMENTAL",[18],"Behavioral: CADx delayed",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","CADx simultaneously","The investigators showed the CADx suggestion during the 15-second playback of the video",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"BEHAVIORAL","CADx delayed","During the 15-seconds polyp video the CADx suggestion appear only in the last 3 seconds of the video",[15],[32,36,39],{"name":33,"affiliation":34,"role":35},"Yuichi Mori, MD, PhD","Clinical Effectiveness Research group","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Pedro Davila Piñón, Masters degree biotechnology","Research Group in Gastrointestinal Oncology Ourense \u002F Galicia-Sur Public Galician Foundation",{"name":40,"affiliation":41,"role":35},"Joaquin Cubiella, MD, PhD","University Hospital of Ourense",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Pedro Davila Piñón, Master degree in biotechnology","CONTACT","+34 988385047","285047","pedro.davila@iisgaliciasur.es",{"name":40,"role":45,"phone":46,"phoneExt":47,"email":50},"joaquin.cubiella.fernandez@sergas.es",[52,68],{"facility":53,"status":25,"city":54,"state":25,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Clinical Effectiveness Research Group","Oslo","0424","Norway","NO",{"type":59,"coordinates":60},"Point",[61,62],10.74609,59.91273,{"lat":62,"lon":61},[65],{"name":33,"role":45,"phone":66,"phoneExt":25,"email":67},"(+47) 934 81 380","yuichi.mori@medisin.uio.no",{"facility":69,"status":25,"city":70,"state":25,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Research Group in Gastrointestinal Oncology Ourense","Ourense","32005","Spain","ES",{"type":59,"coordinates":75},[76,77],-7.86407,42.33669,{"lat":77,"lon":76},[80,82],{"name":81,"role":45,"phone":46,"phoneExt":47,"email":48},"Pedro Davila, Master Degree in biotechnology",{"name":40,"role":45,"phone":46,"phoneExt":47,"email":50},{"type":84,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":97,"type":98},70,"ESTIMATED","INTERVENTIONAL",[101],"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.",[104,105,106,107,108,109,110,111],"Polyps Colorectal","Colonoscopy","Optical Biopsy","Colorectal Cancer Control and Prevention","Colorectal Cancer Screening","Behavior Change","Psychological Factors","Psychological Intervention",[113,114,115,116,117,118],"behaviour","optical biopsy","colonoscopy","CADx system","colorectal polyps","psychological intervention","NOT_YET_RECRUITING","2025-08-28",{"date":122,"type":123},"2025-09-05","ACTUAL",{"date":125,"type":98},"2025-09",{"date":127,"type":98},"2025-12",{"name":5,"class":6},2]