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AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment
Sponsor: Servicio de Salud Metropolitano Sur Oriente
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.
Official title: FECAL-AI: Prospective Observational Validation of AI-Based Stool Image Analysis Against Quantitative Fecal Immunochemical Testing for Colorectal Neoplasia Risk Assessment
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2026-05-08
Completion Date
2026-12
Last Updated
2026-07-31
Healthy Volunteers
Not specified
Conditions
Interventions
AI-Based Stool Image Analysis
Participants capture stool images using the FAEX Health mobile application. Coded images are analyzed using artificial intelligence algorithms to derive visual features and a prespecified patient-level output or score. The AI-derived output is used exclusively for research and is compared primarily with quantitative FIT results and FIT positivity, with secondary comparisons against colonoscopy and histopathology when available. The output is not used to provide a diagnosis or guide clinical management.
Locations (1)
Hospital Sotero del Rio
Santiago, Santiago Metropolitan, Chile