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Completed

NCT Number: NCT07563816

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.

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Key information

Conditions

Colonic Polyps Adenoma Adenomatous Polyps Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemocnice Hořovice - NH Hospital a.s., Hořovice, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ColoMaia II software

Device

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

Standard colonoscopy

Procedure

Standard colonoscopy

Primary outcomes

  1. Adenoma Detection Rate (ADR)

    Time frame: Periprocedural

    Proportion of participants with at least 1 adenoma detected, removed, and histologically verified during the index colonoscopy.

  2. 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.

Secondary outcomes

  1. 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.

  2. Adenomas Per Colonoscopy (APC)

    Time frame: Periprocedural

    Mean number of histologically verified adenomas per colonoscopy.

  3. 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.

  4. 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.

  5. 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.

  6. False Acoustic Alerts per Minute

    Time frame: Periprocedural

    Average number of acoustic alerts per minute not associated with any possibly clinically significant lesion.

  7. Erroneous Visual Alerts per Minute

    Time frame: Periprocedural

    Average number of visual alerts per minute not associated with any possibly clinically significant lesion.

  8. Average Alert Delay

    Time frame: Periprocedural

    Average time from first clear lesion visibility until the visual alert is rendered.

  9. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

MAIA Labs s.r.o.

Industry

Registry information

Official study title

Clinical Investigation of the ColoMaia II Software for Supporting Lesion Detection During Colonoscopy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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