Clinical trial · Interventional
Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.
A Multicenter Study to Evaluate the Diagnostic Performance of Computer-aided Polyp Size Classification of the MAGENTIQ-COLO During Real-time Colonoscopy
NCT06568523CI-TRIAL-00080124unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Screening Colonoscopy | — | UNRESOLVED | — |
| Surveillance Colonoscopy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MAGENTIQ-COLO. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology.
- description
- Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO.
- interventionNames
- Diagnostic Test: MAGENTIQ-COLO.
Primary outcomes (1)
- measure
- The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard.
- timeFrame
- During the Colonoscopy Procedure
- description
- The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (\>5mm) compared to the reference gold standard, which is the size classification of the colorectal polyp using open biopsy forceps, or polypectomy snare, of known diameter. The diagnostic performance of the CADx-assisted optical diagnosis to correctly classify colorectal polyps as diminutive (≤5mm) or non-diminutive (\>5mm) compared to size classification using open biopsy forceps, or polypectomy snare, of known diameter. This will be measured by the sensitivity and specificity of the CADx-assisted optical diagnosis compared to an expected minimum of 70% sensitivity and 70% specificity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals aged ≥45 - ≤80 years old, who are scheduled for non-iFOBT screening or surveillance colonoscopy. Exclusion Criteria: 1. In situ polyps with known histology detected in a previous colonoscopy. 2. No colorectal polyps detected during colonoscopy. 3. Known or suspected inflammatory bowel disease. 4. Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis). 5. Non-hereditary polyposis syndromes (e.g. Lynch syndrome). 6. History of chemotherapy or radiation therapy for colorectal lesions. 7. Pregnancy. 8. Has a referral for therapeutic procedure (i.e., endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.). 9. Inability to undergo polypectomy (e.g., incorrect continued use of anticoagulants, comorbidities) or patient refusal, as assessed by the endoscopist. 10. Inability to provide informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.