NCT07158203Not yet recruiting
Optical Diagnosis of Neoplasia Using Artificial Intelligence
Assistance for Optical Diagnosis of Neoplasia Using Artificial Intelligence (FAIR Study)
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- Oct 2026
- Primary completion date
- Nov 2026
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Diseases
- Colorectal cancer
- NCT number
- NCT07158203
What you commit to
- Study type: Interventional
- Planned participants: 70
- From Oct 2026 to the primary completion date, Nov 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Group in Gastrointestinal Oncology Ourense Coordinator of this site? Confirm its status | Ourense | Spain | Unknown status |
| Clinical Effectiveness Research Group Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.