Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400875
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2024-04-27
Brief Title:
Observational Study to Investigate the Use of Sterilized Porcine Placental Tissue in the Treatment of Chronic VLU
Sponsor:
ConvaTec Inc
Organization:
ConvaTec Inc
Study Overview
Official Title:
A Prospective Multi Center Observational Study to Investigate the Safety and Effectiveness of Sterilized Porcine Placental Tissue in the Treatment of Chronic Venous Leg Ulcers
Status:
COMPLETED
Status Verified Date:
2024-05
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 study is a multi-center prospective clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs The trial will include 30 completed subjects at multiple experienced clinical centers in the United States
Detailed Description:
None
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