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ColoMaia II Software to Support Lesion Detection During Colonoscopy
Sponsor: MAIA Labs s.r.o.
Summary
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.
Official title: Clinical Investigation of the ColoMaia II Software for Supporting Lesion Detection During Colonoscopy
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-11-11
Completion Date
2026-05-08
Last Updated
2026-06-18
Healthy Volunteers
No
Interventions
ColoMaia II software
AI software providing real-time visual and acoustic alerts during colonoscopy
Standard colonoscopy
Standard colonoscopy
Locations (3)
Nemocnice Hořovice - NH Hospital a.s.
Hořovice, Czechia
Nemocnice AGEL Nový Jičín a.s.
Nový Jičín, Czechia
Nemocnice AGEL Ostrava-Vítkovice a.s.
Ostrava, Czechia