Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07563816
NA

ColoMaia II Software to Support Lesion Detection During Colonoscopy

Sponsor: MAIA Labs s.r.o.

View on ClinicalTrials.gov

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

DEVICE

ColoMaia II software

AI software providing real-time visual and acoustic alerts during colonoscopy

PROCEDURE

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