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

NCT ID: NCT06449378

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-02
• Study Completion Date: 2030-10-01

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hernia Repair

single arm study, no control arm

Group Type: EXPERIMENTAL

Transorb™ Self-Gripping Resorbable Mesh

Intervention Type: DEVICE

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

Interventions

Transorb™ Self-Gripping Resorbable Mesh

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

Intervention Type: DEVICE

Eligibility Criteria

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.

2. Smokers with a minimum 20 pack year history (including former smokers)

3. Obesity, defined as body Mass Index (BMI) between 30kg/m2 and 39.9kg/m2

4. Chronic Obstructive Pulmonary Disease (COPD)

5. Diabetes mellitus

6. History of wound infection

7. Malnutrition (serum albumin less than 3.4 g/d)

8. Coronary Artery Disease (CAD)

9. History of chemotherapy

10. Diagnosis of hypertension

11. History of malignancy without evidence of active disease

12. Renal insufficiency (serum creatinine concentration ≥2.5 mg/d)

5. Subject who will require more than a single piece of Transorb™ or any other additional mesh

6. Subject with anticipated inability to achieve both:

1. Midline anterior and posterior rectus fascia closure without excessive tension, and

2. Skin closure

7. Subject who is otherwise no longer eligible to receive Transorb™ in open retrorectus/retromuscular position with or without Transversus Abdominis Release (TAR).

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)

4. Liver cirrhosis and/or current ascites

5. Renal disease requiring dialysis

6. Bleeding disorder and/or cannot be removed from anticoagulants prior to surgery based on surgeon discretion and standard-of-care (excluding aspirin)

7. Chronic immunosuppression therapy (10 mg or greater of prednisone or equivalence/ day)

8. Current or anticipated chemotherapy/radiotherapy during study period

9. Stoma

10. Any systemic or local ongoing infection that is uncontrolled and/or requiring treatment such as antimicrobial medication (Note: other uses of antimicrobial medications not excluded)

5. Subject has life expectancy of less than 5 years based on the judgement of investigator

6. Subject is pregnant or is planning pregnancy within the 60-month follow-up period (females of childbearing potential will be required to provide either a urine or serum pregnancy test, except for subjects who are surgically sterile, or are at least 2 years post-menopausal)

7. Subject is breastfeeding or is planning to breastfeed during the study duration period

8. Subject has any other medical condition that precludes the subject from participation, in the opinion of the investigator

9. Subject is undergoing:

1. Minimally invasive hernia repair (i.e., laparoscopic or robotic surgery)

2. An emergency surgery (i.e., lifesaving procedures performed where subject is in imminent danger of death)

3. Multi-stage hernia repair

4. Parastomal hernia repair

5. Concomitant ostomy (creation or closure)

6. Any other additional anticipated surgery, if subsequent surgery that would jeopardize previous application of study device, in the opinion of the investigator

10. Subject is American Society of Anesthesiology Class 4, 5, or 6

11. Subject has a BMI greater than or equal 40.0 kg/m2

12. Subject is pregnant or is planning pregnancy within the 60-month follow-up period (females of childbearing potential will be required to provide either a urine or serum pregnancy test, except for subjects who are surgically sterile, or are at least 2 years post-menopausal)

1. Subject has existing mesh from previous ventral hernia surgery that investigator was unable to completely remove

2. Subject has concomitant diastasis (>2 cm) that was not repaired

3. Hernia defect that will require a multi-stage repair

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Goldblatt, MD, FACS

Role: STUDY_CHAIR

Medical College of Wisconsin

Bruce Ramshaw, MD, FACS

Role: STUDY_CHAIR

J. Scott Roth, MD, FACS

Role: STUDY_CHAIR

University of Kentucky

Frederik Berrevoet, Prof. Dr.

Role: STUDY_CHAIR

University Hospital, Ghent

Yohann Renard, Prof.

Role: STUDY_CHAIR

CHU de Reims

Locations

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

Countries

United States; Belgium; France

References

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.

Reference Type: DERIVED

PMID: 40675633 (View on PubMed)

Other Identifiers

MDT21008

Identifier Type: -

Identifier Source: org_study_id