Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05523271
Status:
RECRUITING
Last Update Posted:
2023-01-19
First Post:
2022-08-29
Brief Title:
A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care White Light
Sponsor:
Theodor Bilharz Research Institute
Organization:
Theodor Bilharz Research Institute
Study Overview
Official Title:
A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care
Status:
RECRUITING
Status Verified Date:
2023-01
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:
This study is to assess the sensitivity and added benefits of CADEYE compared to standard care white-light in detecting colon polyps in patients undergoing colonoscopy
Detailed Description:
Failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms In response technological advances have paved the way for Computer-Aided Polyp Detection CAD-e systems Artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy CADEYE is a CAD-e system FUJIFILM that enables real-time video processing at the same rate as the standard procedure
The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care
The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care
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