Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Polyp
- Sponsor
- Iterative Scopes, Inc
- Enrollment
- 1472
- Locations
- 5
- Primary Endpoint
- Adenomas per colonoscopy
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Adenomas per colonoscopy
Time Frame: At the end of the procedure, 1 day
The total number of adenomas detected divided by the total number of colonoscopies.
Positive predictive value
Time Frame: At the end of the procedure, 1 day
The total number of adenomas and serrated lesions detected divided by the total number of extractions.
Secondary Outcomes
- Adenoma detection rate(At the end of the procedure, 1 day)
- Colorectal cancer surveillance interval(At the end of the procedure, 1 day)
- Sessile serrated lesions detected(At the end of the procedure, 1 day)