RecruitingNCT07740122

AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment

FECAL-AI: Prospective Observational Validation of AI-Based Stool Image Analysis Against Quantitative Fecal Immunochemical Testing for Colorectal Neoplasia Risk Assessment

Sponsor

Servicio de Salud Metropolitano Sur Oriente

Enrollment

250 participants

Start Date

May 8, 2026

Study Type

OBSERVATIONAL

Conditions

Colorectal Neoplasms

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying AI-Based Stool Image Analysis for people with colorectal neoplasms. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTAI-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

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NCT07740122

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