Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384183
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-26
First Post:
2024-04-22
Brief Title:
Kerecis Real-World Fish Skin Graft Registry
Sponsor:
Kerecis Ltd
Organization:
Kerecis Ltd
Study Overview
Official Title:
Kerecis Real-World Fish Skin Graft Registry - ISACOD
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
ISACOD
Brief Summary:
Multi-center observational ie non-interventional open-label real-world Registry on the Use of Kerecis Devices
Detailed Description:
This observational ie non-interventional post-market real-world Registry was designed to collect analyze and identify relevant safety and performance outcomes for all comers using Kerecis devices in routine medical practice within a wide variety of United States US medical practice settings These clinical data will be used at Kerecis for many purposes which include but are not limited to device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None