Colonic PolypsNCT07563816
ColoMaia II Software to Support Lesion Detection During Colonoscopy
A study testing ColoMaia II software and Standard colonoscopy in people with Colonic Polyps and Adenomatous Polyps, run by MAIA Labs s.r.o. at 3 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Colonic Polyps, Adenomatous Polyps, Colorectal Neoplasms
- What is being tested?
- ColoMaia II software and Standard colonoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesCzechia
- Study dates
- 11 Nov 2025to 8 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40-80 years, indicated for screening, surveillance, or diagnostic colonoscopy.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
Nemocnice Hořovice - NH Hospital a.s.
Hořovice, 26801
Nemocnice AGEL Nový Jičín a.s.
Nový Jičín, 74101
Nemocnice AGEL Ostrava-Vítkovice a.s.
Ostrava, 70300
About this study
Official title: 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.
- Conditions
- Colonic Polyps, Adenomatous Polyps, Colorectal Neoplasms
- Being tested
- ColoMaia II software, Standard colonoscopy
- Medical subject headings
- Colonic Polyps, Adenomatous Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColoMaia II softwareDevice
AI software providing real-time visual and acoustic alerts during colonoscopy
Standard colonoscopyProcedure or surgery
Standard colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| ColoMaia II-Assisted Colonoscopy | Experimental | Not described Receives: Device: ColoMaia II software |
| Standard Colonoscopy | Active comparator | Not described Receives: Procedure: Standard colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR)
Proportion of participants with at least 1 adenoma detected, removed, and histologically verified during the index colonoscopy.
Measured: 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.
Measured: Periprocedural
Secondary outcomes (9)
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.
Measured: Immediately after the index colonoscopy procedure
Adenomas Per Colonoscopy (APC)
Mean number of histologically verified adenomas per colonoscopy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Periprocedural
False Acoustic Alerts per Minute
Average number of acoustic alerts per minute not associated with any possibly clinically significant lesion.
Measured: Periprocedural
Erroneous Visual Alerts per Minute
Average number of visual alerts per minute not associated with any possibly clinically significant lesion.
Measured: Periprocedural
Average Alert Delay
Average time from first clear lesion visibility until the visual alert is rendered.
Measured: 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.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start11 Nov 2025
- Primary completion11 Apr 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- MAIA Labs s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563816
- Sponsor's protocol ID
- MaiaLabs-2025-001
- Status last verified
- Jun 2026
- First submitted
- 23 Apr 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the ColoMaia II Software for Supporting Lesion Detection During Colonoscopy
- ClinicalTrials.gov ID
- NCT07563816
- Acronym / sponsor ID
- MaiaLabs-2025-001
- Conditions
- Colonic Polyps, Adenomatous Polyps, Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- MAIA Labs s.r.o.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 11 Apr 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ColoMaia II-Assisted Colonoscopy | Experimental | Device: ColoMaia II software |
| Standard Colonoscopy | Active comparator | Procedure: Standard colonoscopy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 40-80 years, indicated for screening, surveillance, or diagnostic colonoscopy.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColoMaia II softwareAI software providing real-time visual and acoustic alerts during colonoscopy | Device | ColoMaia II-Assisted Colonoscopy |
| Standard colonoscopyStandard colonoscopy | Procedure or surgery | Standard Colonoscopy |
Primary outcome
Adenoma Detection Rate (ADR)
Time frame: Periprocedural
Proportion of participants with at least 1 adenoma detected, removed, and histologically verified during the index colonoscopy.
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.
9 secondary outcomes
Usability Questionnaire Score
Time frame: Immediately after the index colonoscopy procedure
Adenomas Per Colonoscopy (APC)
Time frame: Periprocedural
Positive Percent Agreement (PPA) for Clinically Significant Lesions
Time frame: Periprocedural
Visual Alert Sensitivity for Pre-specified Detection Delays
Time frame: Periprocedural
Acoustic Alert Sensitivity for Pre-specified Detection Delays
Time frame: Periprocedural
False Acoustic Alerts per Minute
Time frame: Periprocedural
Erroneous Visual Alerts per Minute
Time frame: Periprocedural
Average Alert Delay
Time frame: Periprocedural
Average Percentage of Time With an Incorrect Visual Alert
Time frame: Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ColoMaia II software and Standard colonoscopy in people with Colonic Polyps and Adenomatous Polyps, run by MAIA Labs s.r.o. at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Detection Rate (ADR) (time frame: Periprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.