Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449378
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-22
Brief Title:
Transorb Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia
Sponsor:
Medtronic - MITG
Organization:
Medtronic - MITG
Study Overview
Official Title:
Multi-center Single-arm Prospective Study of Transorb Self-Gripping REsorbable Mesh in High-risk subjeCts Undergoing Open Repair of VEntral heRnia
Status:
RECRUITING
Status Verified Date:
2024-09
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:
RECOVER
Brief Summary:
The purpose of RECOVER is to evaluate the performance and safety of Transorb self-gripping resorbable mesh in high-risk subjects at least one risk factor impairing wound healing when used for reinforcement of abdominal wall soft tissues in procedures involving open extraperitoneal ventral hernia repair in clean US and clean and clean-contaminated Europe surgical fields Centers for Disease Control and Prevention CDC Classification I and II Data from this study will primarily be used to support market approval and European post-market clinical follow-up needs Secondarily data will be used for product marketing future product development and to support market release and maintenance in global geographies
Detailed Description:
The primary objective of the study is to evaluate the performance hernia clinical recurrence rate of Transorb mesh within 12 months post-operatively when the mesh is used for repair of open ventral hernia
The secondary objectives of the study are to evaluate the safety and performance of Transorb mesh when used for repair of open ventral hernia within 60 months post-operatively
The secondary objectives of the study are to evaluate the safety and performance of Transorb mesh when used for repair of open ventral hernia within 60 months post-operatively
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