Artificial Intelligence-assisted Colonoscopy, Tandem Study

The goal of this clinical trial is to evaluate effect of artifial intelligent (AI) system, Endoscopy as AI-powered Device (ENAD) on adenoma miss rate from colonoscopy underwent by trainee endoscopist. It will also evaluate effect of AI on adenoma and polyp detection rate from colonoscopy underwent by trainee endoscopist. The main questions it aims to answer are: • Does AI-system lower adenoma miss rate in colonoscopy underwent by trainee endoscopist? Researchers will do the tandem colonoscopy and devided the participant in 4 groups as follows: A. First pass: trainee; Second pass: expert B. First pass: trainee + AI; Second pass: expert C. First pass: trainee; Second pass: expert + AI D. First pass: trainee+AI; Second pass: expert+AI Participants will take bowel preparation in split dose regimen and nothing per oral for 4 hours. They will underwent colonoscopy as above, with sedation by anesthesiologist. Details on qualities of colonoscopy, polyps detection and pathology results will be recorded.

NCT Number	NCT07023471
Lead Sponsor	Mahidol University
Conditions	Artificial Intelligence (AI), Colonoscopy Education, Adenoma Colon Polyp
Enrollment	364 participants
Start Date	2025-05-13
Primary Completion	2025-05-13 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-24