Clinical trial NCT06449378: Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia
Official title: Multi-center, Single-arm, Prospective Study of Transorb™ Self-Gripping REsorbable Mesh in High-risk subjeCts Undergoing Open Repair of VEntral heRnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hernia
Hernia, Ventral
Hernia, Abdominal
Hernia Abdominal Wall
Keywords: Hernia Recurrence
Hernia
Hernia, Ventral
Hernia, Abdominal
Hernia Abdominal Wall
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2024-06-10
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

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).

Primary outcomes:
measure: Rate of clinical hernia recurrence
timeFrame: within 12 months
Secondary outcomes:
measure: Rate of clinical hernia recurrence
timeFrame: within 1, 6, 24, 36, 48 and 60 months
measure: Rate of clinical hernia recurrence requiring re-operation
timeFrame: within 1, 6, 12, 24, 36, 48 and 60 months
measure: Time to hernia recurrence
timeFrame: Day 0 (day of surgery) through the 60-month visit
measure: Rate of mesh removal related to study device and/or study procedure
timeFrame: within 1, 6, 12, 24, 36, 48 and 60 months
measure: Surgeon satisfaction
timeFrame: Day 0 (day of surgery)
measure: Rate of surgical site occurrence (SSO)
timeFrame: at discharge (post-surgery up to 1-mo), and within 1, 6, 12, 24, 36, 48 and 60 months
measure: Rate of surgical site occurrence (SSO) requiring a procedural intervention (SSOPI)
timeFrame: at discharge (post-surgery up to 1-mo), and within 1, 6, 12, 24, 36, 48 and 60 months
measure: Hospital length of inpatient stay
timeFrame: discharge (post-surgery up to 1-mo)
measure: Rate of hernia recurrence reported by subjects
timeFrame: at 36, 48 and 60 months
measure: Change in subject quality of life (QoL)
timeFrame: baseline compared to 1, 6, 12, 24, 36, 48 and 60 months.
measure: Change in subject-reported pain
timeFrame: baseline compared to 1, 6, 12, 24, 36, 48 and 60 months.
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Endeavor Health
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Wilmington
country: United States
facility: Novant Health New Hanover Regional Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Newport News
country: United States
facility: TPMG General Surgery and Hernia Center
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Colombes
country: France
facility: APHP Hospital Louis Mourier
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims
city: Rouen
country: France
facility: Hôpital Charles Nicolle Centre Hospitalier Universitaire de Rouen
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Medical College of Wisconsin
name: Matthew Goldblatt, MD, FACS
role: STUDY_CHAIR
name: Bruce Ramshaw, MD, FACS
role: STUDY_CHAIR
affiliation: University of Kentucky
name: J. Scott Roth, MD, FACS
role: STUDY_CHAIR
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, Prof. Dr.
role: STUDY_CHAIR
affiliation: CHU de Reims
name: Yohann Renard, Prof.
role: STUDY_CHAIR
References: