Adenomatous Polyps, Colonic Polyps, Colorectal Neoplasms
Conditions
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.
Interventions
DEVICEColoMaia II software
AI software providing real-time visual and acoustic alerts during colonoscopy
PROCEDUREStandard colonoscopy
Standard colonoscopy
Sponsors
MAIA Labs s.r.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate (ADR) | 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) | Periprocedural | Number of serious adverse events considered to have a causal or reasonably possible relationship to the ColoMaia II software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability Questionnaire Score | 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. |
| Adenomas Per Colonoscopy (APC) | Periprocedural | Mean number of histologically verified adenomas per colonoscopy. |
| Positive Percent Agreement (PPA) for Clinically Significant Lesions | Periprocedural | Proportion of clinically significant excised lesions among all excised lesions with histology available. Clinically significant lesions are defined per protocol. |
| Visual Alert Sensitivity for Pre-specified Detection Delays | Periprocedural | Percentage of lesions for which the software renders a visual alert within a specified time interval from first lesion visibility. |
| Acoustic Alert Sensitivity for Pre-specified Detection Delays | Periprocedural | Percentage of lesions for which the software gives an acoustic alert within a specified time interval from first lesion visibility. |
| False Acoustic Alerts per Minute | Periprocedural | Average number of acoustic alerts per minute not associated with any possibly clinically significant lesion. |
| Erroneous Visual Alerts per Minute | Periprocedural | Average number of visual alerts per minute not associated with any possibly clinically significant lesion. |
| Average Alert Delay | Periprocedural | Average time from first clear lesion visibility until the visual alert is rendered. |
| Average Percentage of Time With an Incorrect Visual Alert | Periprocedural | Proportion of video frames containing a visual alert not associated with any possibly clinically significant lesion. |
Countries
Czechia
Outcome results
None listed