Optical Diagnosis of Neoplasia Using Artificial Intelligence

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. The 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: * Intervention group: CADx suggestions will be shown in the last 3 seconds of the 15 second polyp video. * Control group: CADx suggestions will be shown in real-time throughout the playback of the 15 second polyp video. The primary endpoint is sensitivity for high-confidence neoplasia detection, with secondary endpoints assessing endoscopists' reliance on AI. CADx 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.

NCT Number	NCT07158203
Lead Sponsor	Fundacin Biomedica Galicia Sur
Conditions	Polyps Colorectal, Colonoscopy, Optical Biopsy, Colorectal Cancer Control and Prevention, Colorectal Cancer Screening, Behavior Change, Psychological Factors, Psychological Intervention
Enrollment	70 participants
Start Date	2025-09
Primary Completion	2025-11 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-09-05