Status:
COMPLETED
Colorectal Polyp Clinical Decision Support Device Study
Lead Sponsor:
Olympus Corporation of the Americas
Conditions:
Polyp
Colorectal
Eligibility:
All Genders
18+ years
Brief Summary
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
Detailed Description
Prospective, single arm, multicenter study with participating endoscopists comprising a range of clinical experience. Consecutive consented patients meeting the entrance criteria will undergo standar...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Willing and able to provide informed consent
- Subjects undergoing colonoscopy
Exclusion
- Polyposis syndromes including Familial Adenomatous Polyposis Syndrome
- Inflammatory Bowel Disease
- Hereditary Non Polyposis Colorectal Cancer
- Severe coagulopathy
- Subjects scoring less than 6 on the Boston Bowel Prep Score or scoring less than 2 in any colon segment.
- No diminutive polyps detected during colonoscopy
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
2379 Patients enrolled
Trial Details
Trial ID
NCT04437615
Start Date
November 5 2020
End Date
March 30 2023
Last Update
April 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Borland Groover
Jacksonville, Florida, United States, 32256