Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754347
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2021-02-10
Brief Title:
Computer Aided Detection of Polyps in Colonoscopy
Sponsor:
Iterative Scopes Inc
Organization:
Iterative Scopes Inc
Study Overview
Official Title:
Randomized Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None