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Autonomous Artificial Intelligence Versus AI Assisted Human Optical Diagnosis

Study acronym: CADx-Prosp
StatusRecruiting
PhaseNot applicable
Started2024-11-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 22 months later Nov 15, 2024 → Oct 2026
See other at-risk trials from Centre hospitalier de l'Université de Montréal (CHUM)

Amendment history

2026-09-22
critical
Recruitment opened
Primary completion pushed: 2024-11-15 → 2026-10
Completion pushed: 2024-11-15 → 2026-10
2024-11-13
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
Primary completion date2024-08-15→2024-11-15
Completion date2024-08-15→2024-11-15
Start date2024-08-15→2024-11-15
Enrollment target400→540
Study arms2→1
Eligibility criteria+145 characters
Inclusion Criteria: Indication for full colonoscopy. Exclusion Criteria: Known inflammatory bowel disease Active colitis coagulopathy familial polyposis syndrome poor general health, defined as an American Society of Anesthesiologists class >3 emergency colonoscopy
Secondary endpoints5 to 6 entries
Accuracy of optical diagnosis, for polyps 1-10mm, compared with an agreed upon CADx-assisted diagnosis
Primary endpoints1 entry, revised
Accuracy of autonomous CADx system (AI-A) optical diagnosis, for polyps 1-5mm, compared with thean real-timeagreed upon CADx-assisted diagnosis (AI-H)
Study description-20 characters
Our study hypothesis is that autonomousfor diagnosisCADx implementation, instead of using athe novelhigh/low confidence framework, identifying cases with suboptimal diagnostic accuracy could be facilitated through identifying cases in which CADx systemand endoscopist disagreed in their diagnosis. Eliminating such cases might separate out cases with low accuracy when using CADx assisted OD. Since endoscopists have a high sensitivity but low specificity for serrated polyp recognitionOD, isthis non inferior to when the endoscopist verifies or corrects the CADx diagnosis. Our primary objective is [...] [...]
Collaborators-48 characters
Roupen Djinbachian, MD Mahsa Taghiakbari, MD PHD
2024-08-05
minor
Original filing
Computer-aided image-enhanced endoscopy can predict the nature of colorectal polyps with over 90% accuracy. This technology uses artificial intelligence (AI) to analyze video recordings of polyps, learning to make diagnoses in real-time. This means that doctors can get immediate predictions about small polyps during the procedure, reducing the need for separate pathology exams and saving costs, ultimately improving patient care. Human and AI interactions are complex and a framework to reap synergistic effects CADx systems when used by humans to harness optimal performance needs to be established. AI solutions in medicine are usually developed to be used as assistive devices, however, then they rely on humans to correct AI errors. Optical polyp diagnosis is a complex task. Non experts usually achieve diagnostic accuracy in 70-80%. CADx systems have a similar diagnostic accuracy when used autonomously. Clinical evaluation of CADx systems showed that CADx assisted OD performs equally to the operator performance when using non CADx assisted OD. To harness a benefit of clinical CADx implementation we would have to find a way that synergies between human and CADx come into play to eliminate cases in which CADx assisted and/ or human OD results in low diagnostic accuracy and also addresses the problem of serrated polyp recognition.
Trial Details
NCT Number NCT06543862
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Conditions Colonic Polyp, Artificial Intelligence
Enrollment 540 participants
Start Date 2024-11-15
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-21