RecruitingNot ApplicableNCT07066046

Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions

Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions: Randomized Controlled Clinical Trial

Sponsor

Instituto do Cancer do Estado de São Paulo

Enrollment

1,000 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Adenomatous Polyposis Colorectal Cancer (CRC)Colorectal Lesions

Summary

The study aims to evaluate the effectiveness of artificial intelligence-assisted colonoscopy in increasing adenoma detection rate and the accuracy in the characterization of colorectal lesions, compared to standard colonoscopy, in a randomized controlled clinical trial setting.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

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 Criteria10

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).

Interventions

PROCEDUREColonoscopy

This single-center, randomized, open-label clinical trial will assess the effectiveness of artificial intelligence (AI)-assisted colonoscopy versus standard high-definition colonoscopy in detecting and characterizing colorectal lesions. Conducted over 12 months in São Paulo, Brazil, the study will include 100 adult patients undergoing elective colonoscopy. Participants will be stratified by age and randomized (1:1) after sedation. All lesions will be resected, recorded, and analyzed histologically. The intervention group will also include AI output data (CAD EYE). The primary goals are to evaluate adenoma detection rate (ADR) and AI diagnostic accuracy. Given the global burden of colorectal cancer (CRC), particularly in developing countries, this study aims to provide real-world data on the impact of AI in CRC screening.