AI-assisted colonoscopy to find and classify colorectal lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares AI-assisted colonoscopy with standard colonoscopy to measure adenoma detection rate and real-time lesion characterization accuracy. Adults scheduled for elective colonoscopy at Hospital das Clínicas da Faculdade de Medicina da USP are randomized to either AI assistance or usual care, with outcomes recorded by endoscopists and pathology confirmation. Key eligibility excludes prior colorectal cancer, inflammatory bowel disease, polyposis syndromes, recent colorectal surgery, emergency procedures, poor bowel prep, or severe comorbidity (ASA ≥3). Primary endpoints are adenoma detection rate and characterization accuracy, with complete colonoscopy to the cecum and adequate bowel preparation required.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All patients aged 18 years or older, with an elective indication for colonoscopy who sign the informed consent form agreeing to participate in the study.

Exclusion Criteria:

* History of inflammatory bowel disease.
* History of colorectal cancer.
* Personal history of colorectal surgery.
* Contraindication to endoscopic biopsies.
* History of intestinal polyposis syndromes.
* Urgent or emergency cases.
* Presence of severe, decompensated comorbidities, or with a score of 3 or higher according to the American Society of Anesthesiologists (ASA) classification.
* Incomplete colonoscopy that does not reach the cecum.
* Insufficient or inadequate bowel preparation, with a score lower than 6 on the Boston Bowel Preparation Scale.
* Patients who do not agree to participate in the study and do not sign the informed consent form (ICF).

Where it's running

• Hospital das Clínicas da Faculdade de Medicina da USP
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Márcio Roberto Facanali Júnior
• Email: marcio.facanali@hc.fm.usp.br
• Phone: +55 19 99825-2870

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.