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

Running, not enrolling · Not applicable

Conditions studied: Hernia, Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall

In brief

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.

Key facts

Study ID

NCT06449378

Run by

Medtronic - MITG

People needed

163

Starts

2024-07-02

Expected to finish

2030-10-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has provided informed consent
• Subject is 18 years of age or older at the time of consent
• 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)
• Subject is expected to meet the criteria for:
• In the US: a class I / clean wound as defined by the CDC (Centers for Disease Control and Prevention) wound classification
• 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
• Subject has at least one of the following comorbid factors impairing wound healing:
• 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.
• Smokers with a minimum 20 pack year history (including former smokers)
• Obesity, defined as body Mass Index (BMI) between 30kg/m2 and 39.9kg/m2
• Chronic Obstructive Pulmonary Disease (COPD)
• Diabetes mellitus
• History of wound infection
• Malnutrition (serum albumin less than 3.4 g/d)
• Coronary Artery Disease (CAD)
• History of chemotherapy
• Diagnosis of hypertension
• History of malignancy without evidence of active disease
• Renal insufficiency (serum creatinine concentration ≥2.5 mg/d)
• Pre-Operative Exclusion Criteria Assessed during subject screening:
• Subject is involved in another interventional drug or device study
• Subject is unable or unwilling to comply with the study requirements or follow-up schedule
• Subject has a history of:

Where it is running

• 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
• Centre Hospitalier Universitaire de Reims — Reims, France
• Hôpital Charles Nicolle Centre Hospitalier Universitaire de Rouen — Rouen, France
• Hôpitaux Universitaires de Strasbourg — Strasbourg, France

Full record on ClinicalTrials.gov

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