1,000
Participants
Start Date
February 1, 2025
Primary Completion Date
February 1, 2026
Study Completion Date
December 1, 2026
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."
RECRUITING
Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo
Instituto do Cancer do Estado de São Paulo
OTHER