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

NARecruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

February 1, 2026

Study Completion Date

December 1, 2026

Conditions
Colorectal Cancer (CRC)Adenomatous PolyposisColorectal LesionsColorectal Cancer
Interventions
PROCEDURE

Colonoscopy

"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."

Trial Locations (1)

05403-010

RECRUITING

Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo

All Listed Sponsors
lead

Instituto do Cancer do Estado de São Paulo

OTHER