Not Yet RecruitingNot Applicable

Optical Diagnosis of Neoplasia Using Artificial Intelligence

Norway, Spain70 participantsStarted 2025-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity of the optical diagnosis of neoplastic lesions.

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT07158203

SponsorFundacin Biomedica Galicia Sur

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

Contact for this trial

Pedro Davila Piñón, Master degree in biotechnology

+34 988385047 pedro.davila@iisgaliciasur.es

View on ClinicalTrials.gov More Polyps Colorectal trials