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

NCT06449378 | Active Not Recruiting FDA Device

• 1 other identifier: MDT21008
• Study Type: interventional
• Target: 163
• Locations: 3 countries
• Sites: 13

Brief 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

Keywords

Hernia Recurrence; Hernia; Hernia, Ventral; Hernia, Abdominal; Hernia Abdominal Wall

Outcome Measures

Primary Outcomes (1)

• Rate of clinical hernia recurrence

  Occurrence of clinical hernia recurrence evaluated by physical examination and confirmed, if deemed necessary by a study investigator, following site standard of care medical imaging for hernia evaluation.

  within 12 months

Secondary Outcomes (11)

• Rate of clinical hernia recurrence

  within 1, 6, 24, 36, 48 and 60 months

• Rate of clinical hernia recurrence requiring re-operation

  within 1, 6, 12, 24, 36, 48 and 60 months

• Time to hernia recurrence

  Day 0 (day of surgery) through the 60-month visit

• Rate of mesh removal related to study device and/or study procedure

  within 1, 6, 12, 24, 36, 48 and 60 months

• Surgeon satisfaction

  Day 0 (day of surgery)

Study Arms (1)

Hernia Repair

EXPERIMENTAL

single arm study, no control arm

Device: Transorb™ Self-Gripping Resorbable Mesh

Interventions

Transorb™ Self-Gripping Resorbable Mesh DEVICE

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

Hernia Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• 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)

You may not qualify if:

• 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:
• Previous hernia repair involving retrorectus/retromuscular mesh placement or a component separation technique (CST)
• Allergic reactions to products with PLLA/TMC (Poly-L-lactide, poly-trimethylene carbonate copolymer)
• Solid organ transplantation
• Subject has current diagnosis/usage of:
• BMI greater than or equal to 40.0 kg/m2
• Human Immunodeficiency Virus (HIV)
• Collagen formation disorder (such as Ehlers-Danlos syndrome and Marfan's syndrome)
• Liver cirrhosis and/or current ascites
• Renal disease requiring dialysis
• Bleeding disorder and/or cannot be removed from anticoagulants prior to surgery based on surgeon discretion and standard-of-care (excluding aspirin)
• Chronic immunosuppression therapy (10 mg or greater of prednisone or equivalence/ day)
• Current or anticipated chemotherapy/radiotherapy during study period

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (13)

Northwestern University

Evanston, Illinois, 60208, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

TPMG General Surgery and Hernia Center

Newport News, Virginia, 23606, United States

Location

UZ Leuven, campus Gasthuisberg

Leuven, Belgium

Location

APHP Hospital Louis Mourier

Colombes, 92700, France

Location

Centre Hospitalier Universitaire de Lille

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Centre Hospitalier Universitaire de Reims

Reims, France

Location

Hôpital Charles Nicolle Centre Hospitalier Universitaire de Rouen

Rouen, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

Related Publications (1)

• Roth JSS, Ramshaw B, Renard Y, Passot G, Berrevoet F, Bayliss K, Blanc M, Cain C, Goldblatt M. New synthetic resorbable mesh for open ventral hernia repair: the multicentre, single-arm, prospective study of Transorb self-gripping resorbable mesh in subjects undergoing open repair of ventral hernia in clean and clean-contaminated fields (RECOVER) protocol. BMJ Open. 2025 Jul 17;15(7):e100294. doi: 10.1136/bmjopen-2025-100294.

  PMID: 40675633 DERIVED

MeSH Terms

Conditions

Hernia; Hernia, Ventral; Hernia, Abdominal

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Goldblatt, MD, FACS

  Medical College of Wisconsin

  STUDY CHAIR

• Bruce Ramshaw, MD, FACS

  STUDY CHAIR

• J. Scott Roth, MD, FACS

  University of Kentucky

  STUDY CHAIR

• Frederik Berrevoet, Prof. Dr.

  University Hospital, Ghent

  STUDY CHAIR

• Yohann Renard, Prof.

  CHU de Reims

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 10, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 1, 2030
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); US (6); FR (6)