Clinical Research Directory
Browse clinical research sites, groups, and studies.
Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions
Sponsor: Instituto do Cancer do Estado de São Paulo
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.
Official title: Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions: Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2025-02-01
Completion Date
2026-12-01
Last Updated
2025-07-16
Healthy Volunteers
Yes
Interventions
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.
Locations (1)
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil