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Using Transorb™ mesh for hernia repair in high-risk patients

Multi-center, Single-arm, Prospective Study of Transorb™ Self-Gripping REsorbable Mesh in High-risk subjeCts Undergoing Open Repair of VEntral heRnia

Not applicable Interventional Medtronic - MITG · NCT06449378

This study is testing if a new type of mesh can safely help high-risk patients with ventral hernias avoid having their hernias come back after surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment163 (estimated)
Ages18 Years and up
SexAll
SponsorMedtronic - MITG Industry-sponsored
Drugs / interventionschemotherapy, prednisone
Locations12 sites (Evanston, Illinois and 11 other locations)
Trial IDNCT06449378 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of Transorb™ self-gripping resorbable mesh in patients with risk factors that impair wound healing who are undergoing open repair of ventral hernias. The primary focus is on the hernia recurrence rate within 12 months post-surgery, while secondary objectives include assessing safety and performance over a 60-month period. The mesh will be used in clean and clean-contaminated surgical fields, and data collected will support market approval and future product development.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with at least one comorbidity that affects wound healing, undergoing elective open repair of ventral hernias.

Not a fit: Patients without any risk factors impairing wound healing or those undergoing non-elective hernia repairs may not benefit from this study.

Why it matters

Potential benefit: If successful, this could lead to improved outcomes and reduced recurrence rates for patients undergoing hernia repair.

How similar studies have performed: Other studies have shown promising results with similar resorbable mesh approaches, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion 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)

Pre-Operative Exclusion Criteria Assessed during subject screening:

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

   Pre-Operative Exclusion Criteria assessed/confirmed on day of surgery:
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)

Intraoperative Exclusion Criteria Assessed by investigator following reduction of hernia and preparation of the retrorectus/ retromuscular space for mesh placement:

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
4. Subject no longer meets Inclusion Criteria 4
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).

Where this trial is running

Evanston, Illinois and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HerniaHernia, VentralHernia, AbdominalHernia Abdominal WallHernia Recurrence
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.