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Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

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

NCT06449378•Medtronic - MITG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has provided informed consent
•2. Subject is 18 years of age or older at the time of consent
•3. Subject is undergoing a planned, elective, open, single-staged repair of a midline primary or incisional ventral hernia using retrorectus/retromuscular mesh placement with or without Transversus Abdominis Release (TAR)
•4. Subject is expected to meet the criteria for:
•1. In the US: a class I / clean wound as defined by the CDC (Centers for Disease Control and Prevention) wound classification
•2. In Europe: a class I / clean wound or a class II / clean-contaminated wound as defined by the CDC wound classification in compliance with these conditions:
•* No break in the sterile technique, and
•* Entry into gastrointestinal tract with no or minimal spillage
•5. Subject has at least one of the following comorbid factors impairing wound healing:
•1. Current smokers (subject who has smoked 100 cigarettes in his or her lifetime and who currently smokes) Note: Use smoking status prior to preoperative optimization for inclusion assessment.
+16 more criteria

Exclusion Criteria

•1. Subject is involved in another interventional drug or device study
•2. Subject is unable or unwilling to comply with the study requirements or follow-up schedule
•3. Subject has a history of:
•1. Previous hernia repair involving retrorectus/retromuscular mesh placement or a component separation technique (CST)
•2. Allergic reactions to products with PLLA/TMC (Poly-L-lactide, poly-trimethylene carbonate copolymer)
•3. Solid organ transplantation
•4. Subject has current diagnosis/usage of:
•1. BMI greater than or equal to 40.0 kg/m2
•2. Human Immunodeficiency Virus (HIV)
•3. Collagen formation disorder (such as Ehlers-Danlos syndrome and Marfan's syndrome)
+24 more criteria

Locations (13)

Northwestern University

Evanston, Illinois, United States

University of Kentucky

Lexington, Kentucky, United States

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

TPMG General Surgery and Hernia Center

Newport News, Virginia, United States

UZ Leuven, campus Gasthuisberg

Leuven, Belgium

APHP Hospital Louis Mourier

Colombes, France

Centre Hospitalier Universitaire de Lille

Lille, France

Hospices Civils de Lyon

Lyon, France

Key Dates

Start Date

July 2, 2024

Primary Completion Date

September 15, 2026

Completion Date

October 1, 2030

Last Updated

August 1, 2025

Enrollment

163

ESTIMATED participants

Conditions

HerniaHernia, VentralHernia, AbdominalHernia Abdominal Wall

Interventions

Transorb™ Self-Gripping Resorbable Mesh

DEVICE

Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment

NCT07476560

Abdominal Wall HerniaUmbilical Hernia Repair+1 more

View study

RECRUITINGNA

Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.

NCT07461558

Inguinal Hernia BilateralInguinal Hernia Unilateral

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment

Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.

Ultrasound-Guided Transversus Abdominis Plane Block Versus Epidural Block for Umbilical Hernia Analgesia

Ventral Hernias Following Cytoreductive Surgery : Incidence, Risk Factors and Surgical Management.

A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot

Cytokine Response to Abdominal Wall Reconstruction