ColoMaia II Software to Support Lesion Detection During Colonoscopy

June 16, 2026 updated by: MAIA Labs s.r.o.

Clinical Investigation of the ColoMaia II Software for Supporting 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Hořovice, Czechia, 26801
        • Nemocnice Hořovice - NH Hospital a.s.
      • Nový Jičín, Czechia, 74101
        • Nemocnice AGEL Nový Jičín a.s.
      • Ostrava, Czechia, 70300
        • Nemocnice AGEL Ostrava-Vítkovice a.s.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 40-80 years, indicated for screening, surveillance, or diagnostic colonoscopy.

Exclusion Criteria:

  • Patients with active inflammatory bowel disease, known familial polyposis, contraindication to polypectomy, personal history of colorectal cancer (CRC), prior resection of the colon, patients who do not provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Colonoscopy
Procedure: Standard colonoscopy
Standard colonoscopy
Experimental: ColoMaia II-Assisted Colonoscopy
Device: ColoMaia II software
AI software providing real-time visual and acoustic alerts during colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma Detection Rate (ADR)
Time Frame: Periprocedural
Proportion of participants with at least 1 adenoma detected, removed, and histologically verified during the index colonoscopy.
Periprocedural
Incidence of Serious Adverse Device Effects (SADE)
Time Frame: Periprocedural
Number of serious adverse events considered to have a causal or reasonably possible relationship to the ColoMaia II software.
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability Questionnaire Score
Time Frame: Immediately after the index colonoscopy procedure
The System Usability Scale (SUS) is a standardized 10-item questionnaire used to assess perceived usability of the investigational device. Each item is rated on a 5-point Likert scale. Responses are converted to a total SUS score ranging from 0 to 100, with higher scores indicating better usability.
Immediately after the index colonoscopy procedure
Adenomas Per Colonoscopy (APC)
Time Frame: Periprocedural
Mean number of histologically verified adenomas per colonoscopy.
Periprocedural
Positive Percent Agreement (PPA) for Clinically Significant Lesions
Time Frame: Periprocedural
Proportion of clinically significant excised lesions among all excised lesions with histology available. Clinically significant lesions are defined per protocol.
Periprocedural
Visual Alert Sensitivity for Pre-specified Detection Delays
Time Frame: Periprocedural
Percentage of lesions for which the software renders a visual alert within a specified time interval from first lesion visibility.
Periprocedural
Acoustic Alert Sensitivity for Pre-specified Detection Delays
Time Frame: Periprocedural
Percentage of lesions for which the software gives an acoustic alert within a specified time interval from first lesion visibility.
Periprocedural
False Acoustic Alerts per Minute
Time Frame: Periprocedural
Average number of acoustic alerts per minute not associated with any possibly clinically significant lesion.
Periprocedural
Erroneous Visual Alerts per Minute
Time Frame: Periprocedural
Average number of visual alerts per minute not associated with any possibly clinically significant lesion.
Periprocedural
Average Alert Delay
Time Frame: Periprocedural
Average time from first clear lesion visibility until the visual alert is rendered.
Periprocedural
Average Percentage of Time With an Incorrect Visual Alert
Time Frame: Periprocedural
Proportion of video frames containing a visual alert not associated with any possibly clinically significant lesion.
Periprocedural

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion-Type Specific Detection Outcomes
Time Frame: Periprocedural
Exploratory evaluation of frequency and detection outcomes for specific lesion types, including serrated lesions, clinically significant polyps, advanced adenoma, small adenoma, flat adenoma, and proximal adenoma.
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MAIA Labs s.r.o.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Actual)

April 11, 2026

Study Completion (Actual)

May 8, 2026

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MaiaLabs-2025-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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