Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04195646
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2019-12-10
Brief Title:
Computer Aided Detection of Polyps During Colonoscopy Procedures
Sponsor:
EndoVigilant Inc
Organization:
EndoVigilant Inc
Study Overview
Official Title:
Computer Aided Detection of Polyps During Colonoscopy Procedures
Status:
COMPLETED
Status Verified Date:
2021-09
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 focus of the study is to evaluate impact on Adenomas Per Colonoscopy APC with a Computer Aided Detection CAD software assisting the gastroenterologist during a colonoscopy procedure
Detailed Description:
The details of the proposed study are as follows
1 Colonoscopy will be performed in the same standard of care manner as if no study was taking place The video signal from the colonoscope will be fed into a computer running the EndoVigilant CAD software in addition to the standard video output to the procedure monitor The EndoVigilant CAD software will display an annotated video on an additional monitor that includes both the colonoscopy picture and annotation by the software indicating the location of any polyps on the screen
2 The endoscopist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the annotated video on the second monitor
3 The endoscopist will primarily rely on the second monitor augmented with annotation from EndoVigilant ColonCAD software but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion polypectomy etc
1 Colonoscopy will be performed in the same standard of care manner as if no study was taking place The video signal from the colonoscope will be fed into a computer running the EndoVigilant CAD software in addition to the standard video output to the procedure monitor The EndoVigilant CAD software will display an annotated video on an additional monitor that includes both the colonoscopy picture and annotation by the software indicating the location of any polyps on the screen
2 The endoscopist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the annotated video on the second monitor
3 The endoscopist will primarily rely on the second monitor augmented with annotation from EndoVigilant ColonCAD software but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion polypectomy etc
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