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HerniaRECOVERNCT06449378

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

A study testing Transorb™ Self-Gripping Resorbable Mesh in people with Hernia and Hernia, Ventral, run by Medtronic - MITG at 13 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hernia, Hernia, Ventral, Hernia, Abdominal
What is being tested?
Transorb™ Self-Gripping Resorbable Mesh
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
13 sitesin 3 countries
Study dates
2 Jul 2024to 1 Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 64Show fewer
  • 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:
  • 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
  • Stoma
  • 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)
  • Subject has life expectancy of less than 5 years based on the judgement of investigator
  • 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)
  • Subject is breastfeeding or is planning to breastfeed during the study duration period
  • Subject has any other medical condition that precludes the subject from participation, in the opinion of the investigator
  • Subject is undergoing:
  • Minimally invasive hernia repair (i.e., laparoscopic or robotic surgery)
  • An emergency surgery (i.e., lifesaving procedures performed where subject is in imminent danger of death)
  • Multi-stage hernia repair
  • Parastomal hernia repair
  • Concomitant ostomy (creation or closure)
  • 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:
  • Subject is American Society of Anesthesiology Class 4, 5, or 6
  • Subject has a BMI greater than or equal 40.0 kg/m2
  • 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:
  • Subject has existing mesh from previous ventral hernia surgery that investigator was unable to completely remove
  • Subject has concomitant diastasis (>2 cm) that was not repaired
  • Hernia defect that will require a multi-stage repair
  • Subject no longer meets Inclusion Criteria 4
  • Subject who will require more than a single piece of Transorb™ or any other additional mesh
  • Subject with anticipated inability to achieve both:
  • Midline anterior and posterior rectus fascia closure without excessive tension, and
  • Skin closure
  • Subject who is otherwise no longer eligible to receive Transorb™ in open retrorectus/retromuscular position with or without Transversus Abdominis Release (TAR).

Who cannot join

None listed.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

United States6 sites

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Northwestern University

    Evanston, Illinois, 60208

  • University of Kentucky

    Lexington, Kentucky, 40506

  • TPMG General Surgery and Hernia Center

    Newport News, Virginia, 23606

  • Novant Health New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

Other trials in United States

France6 sites

  • APHP Hospital Louis Mourier

    Colombes, 92700

  • Centre Hospitalier Universitaire de Lille

    Lille

  • Hospices Civils de Lyon

    Lyon

  • Centre Hospitalier Universitaire de Reims

    Reims

  • Hôpital Charles Nicolle Centre Hospitalier Universitaire de Rouen

    Rouen

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg

Other trials in France

Belgium1 site

  • UZ Leuven, campus Gasthuisberg

    Leuven

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
Transorb™ Self-Gripping Resorbable Mesh
Keywords
Hernia Recurrence, Hernia, Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall
Medical subject headings
Hernia, Hernia, Ventral, Hernia, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transorb™ Self-Gripping Resorbable MeshDevice

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

Study groups in NCT06449378
Study groupRoleWhat they receive
Hernia RepairExperimentalsingle arm study, no control arm
Receives: Device: Transorb™ Self-Gripping Resorbable Mesh

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: within 12 months

Secondary outcomes (11)

  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.

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

  2. Rate of clinical hernia recurrence requiring re-operation

    Occurrence of operative procedures performed with the specific goal of repairing a recurrent hernia

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

  3. Time to hernia recurrence

    Days/months to hernia recurrence measured from study procedure to clinical hernia recurrence

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

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

    Occurrence of study mesh removal related to study device and/or study procedure (defined as study device implantation following reduction of hernia and preparation of the retrorectus/retromuscular space)

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

  5. Surgeon satisfaction

    Surgeon satisfaction questionnaire on mesh use

    Measured: Day 0 (day of surgery)

  6. Rate of surgical site occurrence (SSO)

    Occurrence of SSO defined as seroma, hematoma, wound dehiscence, or surgical site infection (SSI) that are adverse events related to study device and/or study procedure (defined as study device implantation following reduction of hernia and preparation of the retrorectus/retromuscular space)

    Measured: at discharge (post-surgery up to 1-mo), and within 1, 6, 12, 24, 36, 48 and 60 months

  7. Rate of surgical site occurrence (SSO) requiring a procedural intervention (SSOPI)

    Occurrence of SSO defined as seroma, hematoma, wound dehiscence, or surgical site infection (SSI) that are adverse events related to study device and/or study procedure (defined as study device implantation following reduction of hernia and preparation of the retrorectus/retromuscular space) and requiring a procedural intervention (defined as percutaneous drainage, wound opening or debridement, suture excision, or mesh removal (partial or total))

    Measured: at discharge (post-surgery up to 1-mo), and within 1, 6, 12, 24, 36, 48 and 60 months

  8. Hospital length of inpatient stay

    days spent inpatient

    Measured: discharge (post-surgery up to 1-mo)

  9. Rate of hernia recurrence reported by subjects

    Occurrence of subject-reported hernia recurrence through the Ventral Hernia Recurrence Inventory (VHRI)

    Measured: at 36, 48 and 60 months

  10. Change in subject quality of life (QoL)

    Change in subject quality of life (QoL), as measured by the Abdominal Hernia-Q (AHQ) Quality-of-Life survey patient-reported outcome measure

    Measured: baseline compared to 1, 6, 12, 24, 36, 48 and 60 months.

  11. Change in subject-reported pain

    Change in subject-reported pain at the hernia site using a Pain Numeric Rating Scale (NRS) from 0-10, with 0 being no pain and 10 being the worst possible pain

    Measured: baseline compared to 1, 6, 12, 24, 36, 48 and 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2024
  2. Study start2 Jul 2024
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion1 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
163 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06449378
Sponsor's protocol ID
MDT21008
Acronym
RECOVER
Status last verified
Jul 2026
First submitted
22 May 2024
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 40675633

Questions about this trial

What is this clinical trial studying?

A study testing Transorb™ Self-Gripping Resorbable Mesh in people with Hernia and Hernia, Ventral, run by Medtronic - MITG at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 64 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of clinical hernia recurrence (time frame: within 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06449378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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