Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-28 @ 6:55 AM
Study NCT ID:
NCT01969292
Status:
TERMINATED
Last Update Posted:
2016-08-19
First Post:
2013-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy
Sponsor:
Christopher Andrews
Organization:
Study Overview
Official Title:
Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stage 1 Complete; Stage 2 and 3 not pursued
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: