NCT06449378

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 163 (estimated)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hernia
• Hernia, Ventral
• Hernia, Abdominal
• Hernia Abdominal Wall

Interventions

Type	Name	Description
DEVICE	Transorb™ Self-Gripping Resorbable Mesh	Self-Gripping Resorbable Mesh used for repair of open ventral hernia.

Timeline

• Start date: 2024-07-02
• Primary completion: 2026-09-15
• Completion: 2030-10-01
• First posted: 2024-06-10
• Last updated: 2025-08-01

Locations

13 sites across 3 countries: United States, Belgium, France

Regulatory

• FDA-regulated device study