Colorectal Polyp Clinical Decision Support Device Study
NCT04437615 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 2379
Last updated 2025-04-17
Summary
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
Conditions
- Polyp
- Colorectal
- Colonoscopy
Interventions
- PROCEDURE
-
Colonoscopy
Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
- DEVICE
-
Clinical Decision Support Device
The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
Sponsors & Collaborators
-
Olympus Corporation of the Americas
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-05
- Primary Completion
- 2022-09-18
- Completion
- 2023-03-30
Countries
- United States
Study Locations
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