ColoMaia II Software to Support Lesion Detection During Colonoscopy

NCT07563816 | Active Not Recruiting

• 1 other identifier: MaiaLabs-2025-001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Colonic Polyps; Adenomatous Polyps; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• Adenoma Detection Rate (ADR)

  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)

  Number of serious adverse events considered to have a causal or reasonably possible relationship to the ColoMaia II software.

  Periprocedural

Secondary Outcomes (9)

• Usability Questionnaire Score

  Immediately after the index colonoscopy procedure

• Adenomas Per Colonoscopy (APC)

  Periprocedural

• Positive Percent Agreement (PPA) for Clinically Significant Lesions

  Periprocedural

• Visual Alert Sensitivity for Pre-specified Detection Delays

  Periprocedural

• Acoustic Alert Sensitivity for Pre-specified Detection Delays

  Periprocedural

Other Outcomes (1)

• Lesion-Type Specific Detection Outcomes

  Periprocedural

Study Arms (2)

ColoMaia II-Assisted Colonoscopy

EXPERIMENTAL

Device: ColoMaia II software

Standard Colonoscopy

ACTIVE COMPARATOR

Procedure: Standard colonoscopy

Interventions

ColoMaia II software DEVICE

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

ColoMaia II-Assisted Colonoscopy

Standard colonoscopy PROCEDURE

Standard colonoscopy

Standard Colonoscopy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MAIA Labs s.r.o.: lead

Study Sites (3)

Nemocnice Hořovice - NH Hospital a.s.

Hořovice, 26801, Czechia

Location

Nemocnice AGEL Nový Jičín a.s.

Nový Jičín, 74101, Czechia

Location

Nemocnice AGEL Ostrava-Vítkovice a.s.

Ostrava, 70300, Czechia

Location

MeSH Terms

Conditions

Colonic Polyps; Adenomatous Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 4, 2026
• Study Start: November 11, 2025
• Primary Completion: April 11, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CZ (3)