Clinical trial · Interventional
A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )
A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care
NCT05523271CI-TRIAL-00063325unknownN/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 study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAD EYE (Computer Aided Diagnosis ----? | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Patients undergoing White Light Endoscopy (standard of care)
- description
- All subjects in Experimental Arm A will undergo SOC (white-light endoscopy).
- type
- EXPERIMENTAL
- label
- Patients undergoing CAD EYE endoscopy
- description
- All subjects in Experimental Arm B will undergo CADEYE endoscopy.
- interventionNames
- Diagnostic Test: CAD EYE (Computer Aided Diagnosis ----?
Primary outcomes (1)
- measure
- Adenoma detection rate
- timeFrame
- 1 year
- description
- Adenoma detection rate is the primary end point which is the percentage of patients with at least 1 histologically proven adenoma or carcinoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 40-80 years old subjects * Subjects undergoing colonoscopy for the following: o Primary CRC screening * Post-polypectomy surveillance * Work up following FIT positivity * Symptoms/signs suspicions of CRC * Subjects must be willing to give written informed consent for the trial Exclusion Criteria: * Unable to consent * Contraindicated to undergo endoscopy * Hospitalized patient * Patients with the following conditions: * History of colon resection * History of CRC * Antithrombotic therapy precluding colon resection o Inflammatory Bowel Disease (IBD) * Familial Adenomatous Polyposis (FAP) * Pregnant or lactating * Poor bowel preparation: BBPS 0 or 1 in a segment
References
Publications (0)
Data not yet available
No reference posted for this study.