Trials / Completed
CompletedNCT05943288
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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 850 (actual)
- Sponsor
- Olympus Europe SE & Co. KG · Industry
- Sex
- All
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This Study aims to provide insight into whether the application of Artificial Intelligence (Olympus Endoscopy Computer-Aided Detection (CADe) system) increases the detection rate of adenomatous polyps in screening and / or surveillance colonoscopy procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OIP-1 | Olympus Endoscopy Computer-Aided Detection (CADe) system |
Timeline
- Start date
- 2023-04-25
- Primary completion
- 2024-07-31
- Completion
- 2024-07-31
- First posted
- 2023-07-13
- Last updated
- 2025-03-18
Locations
6 sites across 4 countries: Belgium, Germany, Spain, Sweden
Source: ClinicalTrials.gov record NCT05943288. Inclusion in this directory is not an endorsement.