ColoMaia II Software to Support Lesion Detection During Colonoscopy

The goal of this clinical trial is to learn whether the ColoMaia II software can help doctors find colon lesions during colonoscopy and whether it is safe to use in adults aged 40 to 80 years having screening, surveillance, or diagnostic colonoscopy. The main questions it aims to answer are whether the software increases the number of participants in whom at least one adenoma is found, and whether the software is safe to use during colonoscopy. Researchers will compare colonoscopy with ColoMaia II software assistance to standard colonoscopy without the software. Participants will be assigned to a colonoscopy with or without ColoMaia II software assistance, have a colonoscopy performed by a qualified physician, have tissue samples examined if needed, and allow study data and procedure videos to be collected and reviewed.

NCT Number	NCT07563816
Lead Sponsor	MAIA Labs s.r.o.
Conditions	Colonic Polyps, Adenomatous Polyps, Colorectal Neoplasms
Enrollment	600 participants
Start Date	2025-11-11
Primary Completion	2026-04-11 (estimated)
Study Completion	2026-05-08 (estimated)
Updated on ClinicalTrials.gov	2026-06-18