Clinical trial · Interventional
ColoMaia II Software to Support Lesion Detection During Colonoscopy
Clinical Investigation of the ColoMaia II Software for Supporting Lesion Detection During Colonoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
| Colonic Polyps | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ColoMaia II software | Device | — | UNRESOLVED |
| Standard colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ColoMaia II-Assisted Colonoscopy
- interventionNames
- Device: ColoMaia II software
- type
- ACTIVE_COMPARATOR
- label
- Standard Colonoscopy
- interventionNames
- Procedure: Standard colonoscopy
Primary outcomes (2)
- measure
- Adenoma Detection Rate (ADR)
- timeFrame
- Periprocedural
- description
- Proportion of participants with at least 1 adenoma detected, removed, and histologically verified during the index colonoscopy.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available