[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649768":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":10,"responsibleParty":31,"collaborators":10,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":10,"studyType":47,"phases":10,"briefSummary":48,"conditions":49,"keywords":53,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":10},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Diminutive Colorectal Polyps - CADx-Assisted Optical Diagnosis",null,"Consecutive patients aged 45-80 undergoing elective colonoscopy (screening, surveillance, or diagnostic) at CHUM, CUSM, and St. Paul's Hospital who provide written informed consent before the colonoscopy and before sedation, and in whom at least one diminutive polyp (≤5 mm) is detected during the procedure. For each diminutive polyp, the endoscopist first records a CADx-unassisted optical diagnosis and confidence level (electronically locked before device activation), then activates the GI Genius CADx module, and records a final CADx-assisted optical diagnosis and confidence level after viewing the device-provided characterization. All polyps are resected and sent for histopathological examination, which serves as the reference standard.",[13],"Device: GI Genius CADx module (Medtronic)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","GI Genius CADx module (Medtronic)","Computer-aided diagnosis (CADx) device recently approved by Health Canada, used to provide real-time optical characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. For each diminutive polyp detected, the endoscopist first records a CADx-unassisted optical diagnosis (electronically locked before device activation), then activates the GI Genius CADx module, which displays a device-provided characterization. The endoscopist then records a final CADx-assisted optical diagnosis, which may agree or disagree with the device output. The study evaluates the CADx-assisted optical-diagnosis strategy (endoscopist + device combined) rather than autonomous or standalone CADx performance.",[9],[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Daniel von Renteln, Doctor of Medicine (MD), Gastr","CONTACT","514-890-8000","30912","daniel.von.renteln.med@ssss.gouv.qc.ca",{"name":28,"role":23,"phone":24,"phoneExt":29,"email":30},"Samira Hanin, Research Coordinator","30916","samira.hanin.chum@ssss.gouv.qc.ca",{"type":32,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100649768","ai-assisted-optical-diagnosis-cadx-for-diminutive-colorectal-polyps-100649768",false,"NCT07738484","AI-Assisted Optical Diagnosis (CADx) for Diminutive Colorectal Polyps","Prospective Multicenter Validation of an Artificial Intelligence-Assisted Optical Diagnosis Strategy (CADx) for the Real-Time Characterization of Diminutive Colorectal Polyps: A STARD-Compliant Diagnostic Accuracy Study","CADxGIG","Inclusion Criteria:\n\n* Signed informed consent, obtained before the colonoscopy and before sedation\n* Age 45-80 years\n* Indication for elective colonoscopy (screening, surveillance, or diagnostic)\n* At least one diminutive polyp (≤5 mm) detected during the procedure (required for inclusion in the analytic cohort; consented patients without an eligible polyp are documented as screen failures)\n\nExclusion Criteria:\n\n* Known inflammatory bowel disease\n* Active colitis\n* Coagulopathy or thrombocytopenia (INR ≥1.5 or platelets \\\u003C50×10⁹\u002FL)\n* Familial polyposis syndrome\n* American Society of Anesthesiologists classification \\>III\n* Emergency colonoscopy\n* Inadequate bowel preparation (Boston Bowel Preparation Scale \\\u003C6)","ALL","45 Years","80 Years",{"count":45,"type":46},840,"ESTIMATED","OBSERVATIONAL","This study evaluates whether an artificial intelligence system (GI Genius, Medtronic), already approved by Health Canada, can help doctors accurately identify, in real time during colonoscopy, which small colorectal polyps (5 mm or less) need to be monitored (adenomas) versus those that do not (for example, hyperplastic polyps). For each small polyp found, the endoscopist will first record a diagnosis without the help of the artificial intelligence system, then activate the system and record a second diagnosis after seeing its assessment. Both diagnoses will be compared to the final result from standard pathology testing, which remains the reference standard. This is an observational diagnostic accuracy study: it does not change any clinical care. All polyps continue to be removed and sent for pathology analysis as usual, whether or not the artificial intelligence system agrees with the doctor. The study will take place during colonoscopies already scheduled for standard clinical reasons (screening, surveillance, or diagnostic work-up), with no additional visits, blood draws, imaging, or sedation. Approximately 840 participants will be enrolled across three Canadian centres (Santé Québec - CHUM, McGill University Health Centre, and St. Paul's Hospital, Vancouver). The goal is to determine whether this AI-assisted approach helps doctors reach the internationally recognized performance thresholds (at least 80% sensitivity and 80% specificity) needed to support clinical adoption of real-time optical diagnosis, which could eventually reduce unnecessary pathology testing.",[50,51,52],"Colorectal Polyps","Colorectal Adenoma","Diminutive Colorectal Polyp",[54,55,56,57,58,51,59,60,61,62,63,64],"CADx","Computer-Aided Diagnosis","Optical Diagnosis","Colonoscopy","Diminutive Colorectal Polyps","GI Genius","Artificial Intelligence","Diagnostic Accuracy","Real-time Characterization","STARD","Histopathology","NOT_YET_RECRUITING","2026-07-29",{"date":68,"type":69},"2026-07-31","ACTUAL",{"date":71,"type":46},"2026-08",{"date":73,"type":46},"2029-08",{"name":5,"class":6}]