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NCT07158203
Optical Diagnosis of Neoplasia Using Artificial Intelligence
Conditions: Polyps Colorectal, Colonoscopy, Optical Biopsy, Colorectal Cancer Control and Prevention, Colorectal Cancer Screening, Behavior Change, Psychological Factors, Psychological Intervention
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 70
Sponsor: Fundacin Biomedica Galicia Sur
Location: Clinical Effectiveness Research Group Oslo Oslo
Summary
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.
Eligibility Criteria
Endoscopists who meet the following inclusion/exclusion criteria Inclusion criteria
* Endoscopists experienced with more than 100 colonoscopies. Exclusion criteria
* Endoscopists who are involved in the development of the protocol of the present study.
Inclusion and exclusion criteria for the study videos. Inclusion criteria.
* Videos with a duration of 15 seconds including both WL and NBI.
* Videos with diminutive polyps with confirmed pathology. Exclusion criteria.
* Videos with no clear image of the polyps.
* Videos with more than one polyp on-screen.
* Inflammatory bowel disease
* Polyposis
* Hereditary colorectal disease
* Videos which CADx cannot provide sufficient number of outputs.
Source: ClinicalTrials.gov (NCT07158203). StuddyBuddy aggregates publicly available trial information.