Clinical Trial

AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment

Study acronym: FECAL-AI
Recruiting
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Summary
This prospective observational substudy evaluates the association between artificial intelligence-derived features from stool images analyzed using the FAEX Health digital platform and fecal immunochemical test results in adults undergoing colorectal cancer screening or diagnostic evaluation. Participants will capture stool images using a mobile application. The primary analysis will compare AI-derived image outputs with quantitative FIT values and FIT positivity. Secondary exploratory analyses will assess associations with colonoscopy and histopathological findings when these results are available. The platform will be used exclusively for research and will not provide diagnoses, replace clinical evaluation, or influence medical decisions.
Trial Details
NCT Number NCT07740122
Lead Sponsor Servicio de Salud Metropolitano Sur Oriente
Conditions Colorectal Neoplasms
Enrollment 250 participants
Start Date 2026-05-08
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-31