An interventional study of ColoMaia II software and Standard colonoscopy in Colonic Polyps, Adenomatous Polyps and Colorectal Neoplasms, sponsored by MAIA Labs s.r.o.. Completed at 3 sites in Czechia. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by MAIA Labs s.r.o. · Not applicable, Interventional, and Diagnostic
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.
318 studies on the registry are indexed under Colonic Polyps; 54 are open to participants now.
This study's enrollment of 600 is above the median of 270 across 215 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →This is the only study on the registry with MAIA Labs s.r.o. as lead sponsor.
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Exclusion Criteria:
Device: ColoMaia II software
Procedure: Standard colonoscopy
AI software providing real-time visual and acoustic alerts during colonoscopy
Standard colonoscopy
Adenoma Detection Rate (ADR)
Proportion of participants with at least 1 adenoma detected, removed, and histologically verified during the index colonoscopy.
Time frame: 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.
Time frame: Periprocedural
Usability Questionnaire Score
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.
Time frame: Immediately after the index colonoscopy procedure
Adenomas Per Colonoscopy (APC)
Mean number of histologically verified adenomas per colonoscopy.
Time frame: Periprocedural
Positive Percent Agreement (PPA) for Clinically Significant Lesions
Proportion of clinically significant excised lesions among all excised lesions with histology available. Clinically significant lesions are defined per protocol.
Time frame: Periprocedural
Visual Alert Sensitivity for Pre-specified Detection Delays
Percentage of lesions for which the software renders a visual alert within a specified time interval from first lesion visibility.
Time frame: Periprocedural
Acoustic Alert Sensitivity for Pre-specified Detection Delays
Percentage of lesions for which the software gives an acoustic alert within a specified time interval from first lesion visibility.
Time frame: Periprocedural
False Acoustic Alerts per Minute
Average number of acoustic alerts per minute not associated with any possibly clinically significant lesion.
Time frame: Periprocedural
Erroneous Visual Alerts per Minute
Average number of visual alerts per minute not associated with any possibly clinically significant lesion.
Time frame: Periprocedural
Average Alert Delay
Average time from first clear lesion visibility until the visual alert is rendered.
Time frame: Periprocedural
Average Percentage of Time With an Incorrect Visual Alert
Proportion of video frames containing a visual alert not associated with any possibly clinically significant lesion.
Time frame: Periprocedural
Lesion-Type Specific Detection Outcomes
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.
Time frame: Periprocedural
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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