Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions

The goal of this clinical trial is to compare the detection rate of clinically significant serrated lesions (CSSL) in participants undergoing water exchange (WE) colonoscopy with artificial intelligence (AI)-based computer-aided detection (CADe) for screening, surveillance, diagnosis for symptoms, or referred owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. There will be two arms in this study: WE with AI-assisted CADe (WEAID) control and WEAID plus linked-color imaging (LCI). The main question it aims to answer is whether the addition of LCI into WEAID colonoscopy increases CSSL detection rate. Both groups use water instead of air to insert the colonoscope into the cecum. The control method uses CADe to help detect colonic lesions. The study method uses a combination of CADe and LCI to detect lesions. Researchers will compare CSSL detection rate to see if the addition of LCI increases the detection of CSSL during CADe-assisted WE colonoscopy.

NCT Number	NCT07127471
Lead Sponsor	Evergreen General Hospital, Taiwan Collaborators: Centre hospitalier de l'Université de Montréal (CHUM), King Chulalongkorn Memorial Hospital, Valduce Hospital
Conditions	Sessile Colonic Polyp, Serrated Lesion, Sessile Serrated Lesion, Colon Adenomas
Enrollment	1,090 participants
Start Date	2025-11-17
Primary Completion	2027-04-30 (estimated)
Study Completion	2027-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-20