Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy
NCT05943288 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 850
Last updated 2025-03-18
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.
Conditions
Interventions
- DEVICE
-
OIP-1
Olympus Endoscopy Computer-Aided Detection (CADe) system
Sponsors & Collaborators
-
Cromsource
collaborator INDUSTRY -
Olympus Europe SE & Co. KG
lead INDUSTRY
Principal Investigators
-
Karolin Boecker · Olympus Europa SE & Co. KG
Eligibility
- Min Age
- 45 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-25
- Primary Completion
- 2024-07-31
- Completion
- 2024-07-31
Countries
- Belgium
- Germany
- Spain
- Sweden
Study Locations
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