Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT05610267
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2022-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Sponsor:
Integra LifeSciences Corporation
Organization:
Study Overview
Official Title:
A Retrospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Status:
COMPLETED
Status Verified Date:
2024-06
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 purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.
Detailed Description:
Retrospective data will be collected and assessed for early post-operative surgical site events and complications in the immediate post-operative period of 90 days.
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: