Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05237310
Status:
UNKNOWN
Last Update Posted:
2022-03-08
First Post:
2022-02-02
Brief Title:
Comparing Detection of Standard Colonoscopy CAD-EYE and Combined CAD-EYE and G-EYE Aided Colonoscopy
Sponsor:
Smart Medical Systems Ltd
Organization:
Smart Medical Systems Ltd
Study Overview
Official Title:
Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of Standard Colonoscopy to That of Artificial Intelligence CAD-EYE and to That of Artificial Intelligence CAD-EYE and G-EYE Aided Colonoscopy
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
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 purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy ie the adenoma miss-rate reduction obtained by performing CADEYE and G-EYE aided colonoscopy vs the additional diagnostic yield over Standard Colonoscopy ie the adenoma miss-rate reduction obtained by performing CAD-EYE aided colonoscopy
Detailed Description:
The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy ie the adenoma miss-rate reduction obtained by performing CADEYE and G-EYE aided colonoscopy vs the additional diagnostic yield over Standard Colonoscopy ie the adenoma miss-rate reduction obtained by performing CAD-EYE aided colonoscopy This is a single-center four-arm dual-tandem randomized open-label study intended to compare the additional detection yield beyond standard colonoscopy obtained by performing combined CAD-EYE and G-EYE high definition colonoscopy vs the additional detection yield beyond standard colonoscopy obtained by performing CAD-EYE high definition colonoscopy Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None