Clinical trial · Observational
Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy
Safety and Efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) System in Detection of Colorectal Neoplasia's During Real-time Colonoscopy: A European Prospective, Multicenter, Randomized Controlled Trial (EuroCADe)
- 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 a prospective, multicenter, randomized Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. The aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary Colorectal Cancer screening or postpolypectomy surveillance.
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 |
|---|---|---|---|
| OIP-1 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CADe +
- description
- Olympus Endoscopy Computer-Aided Detection (CADe) system
- interventionNames
- Device: OIP-1
- label
- CADe -
- description
- Standard of Care Endoscopy (HD Whitelight)
Primary outcomes (2)
- measure
- Adenoma Detection Rate (ADR)
- timeFrame
- During procedure
- description
- Proportion of patients with at least one histologically confirmed adenoma (including advanced adenomas) or carcinoma in the CADe assisted colonoscopy (CADe+ arm) versus conventional colonoscopy without CAD (CADe- arm).
- measure
- Positive Predictive Value (PPV)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent 2. 45-80 years 3. Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance Exclusion Criteria: 1. Lack of informed written consent 2. History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP) 3. Prior failed colonoscopy * multiple historic prior failed colonoscopy due to poor bowel preparation OR * a single prior failed colonoscopy due to reasons other than poor bowel preparation 4. Biopsy/anesthesia/sedation contraindications 5. History of radio- and/or chemotherapy 6. Concurrent participation in another competing clinical study
References
Publications (0)
Data not yet available