Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869838
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-05-09
Brief Title:
A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies
Sponsor:
Olympus Europe SE Co KG
Organization:
Olympus Europe SE Co KG
Study Overview
Official Title:
Collecting Real-world Data on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies for the Development of a CAD Computer Aided Detection System A Prospective Multicenter Post-market Investigation
Status:
RECRUITING
Status Verified Date:
2023-11
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:
CODACO
Brief Summary:
The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence AI devices for colonoscopies
Detailed Description:
The primary objective of this study is to collect colonoscopy data for use in the development and performance evaluation of AI devices The data will be collected during routine colonoscopy procedures Biopsy or resection will be performed if needed and all specimens will be sent for histopathological examination The histopathological results will be recorded
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