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Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia — RECOVER  

Hernia Clinical Trial

Official title:
Multi-center, Single-arm, Prospective Study of Transorb™ Self-Gripping REsorbable Mesh in High-risk subjeCts Undergoing Open Repair of VEntral heRnia

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06449378
Study type Interventional
Source Medtronic - MITG
Contact Katie Bayliss
Phone +1 763 203 4538
Email katie.j.bayliss@medtronic.com
Status Not yet recruiting
Phase N/A
Start date June 1, 2024
Completion date June 30, 2031
View Details
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