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

NCT06449378 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2025-08-01

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Transorb™ Self-Gripping Resorbable Mesh

Self-Gripping Resorbable Mesh used for repair of open ventral hernia.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Matthew Goldblatt, MD, FACS · Medical College of Wisconsin

  • Bruce Ramshaw, MD, FACS

  • J. Scott Roth, MD, FACS · University of Kentucky

  • Frederik Berrevoet, Prof. Dr. · University Hospital, Ghent

  • Yohann Renard, Prof. · CHU de Reims

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2026-09-15
Completion
2030-10-01
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06449378 on ClinicalTrials.gov