Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07158203
NA

Optical Diagnosis of Neoplasia Using Artificial Intelligence

Sponsor: Fundacin Biomedica Galicia Sur

View on ClinicalTrials.gov

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.

Official title: Assistance for Optical Diagnosis of Neoplasia Using Artificial Intelligence (FAIR Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-09

Completion Date

2025-12

Last Updated

2025-09-05

Healthy Volunteers

Yes

Interventions

DEVICE

CADx simultaneously

The investigators showed the CADx suggestion during the 15-second playback of the video

BEHAVIORAL

CADx delayed

During the 15-seconds polyp video the CADx suggestion appear only in the last 3 seconds of the video

Locations (2)

Clinical Effectiveness Research Group

Oslo, Norway

Research Group in Gastrointestinal Oncology Ourense

Ourense, Spain