ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-02

Study Completion:2030-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06449378

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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) 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 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).	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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)
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
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).

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Matthew Goldblatt, MD, FACS

STUDY_CHAIR

Medical College of Wisconsin

Bruce Ramshaw, MD, FACS

STUDY_CHAIR

J. Scott Roth, MD, FACS

STUDY_CHAIR

University of Kentucky

Frederik Berrevoet, Prof. Dr.

STUDY_CHAIR

University Hospital, Ghent

Yohann Renard, Prof.

STUDY_CHAIR

CHU de Reims

Study Locations (Sites)

Northwestern University

Evanston, Illinois, 60208

United States

University of Kentucky

Lexington, Kentucky, 40506

United States

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, 28401

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

The Ohio State University

Columbus, Ohio, 43210

United States

TPMG General Surgery and Hernia Center

Newport News, Virginia, 23606

United States

Collaborators and Investigators

Sponsor: Medtronic - MITG

Matthew Goldblatt, MD, FACS, STUDY_CHAIR, Medical College of Wisconsin
Bruce Ramshaw, MD, FACS, STUDY_CHAIR
J. Scott Roth, MD, FACS, STUDY_CHAIR, University of Kentucky
Frederik Berrevoet, Prof. Dr., STUDY_CHAIR, University Hospital, Ghent
Yohann Renard, Prof., STUDY_CHAIR, CHU de Reims

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-02

Study Completion Date2030-10-01

Study Record Updates

Study Start Date2024-07-02

Study Completion Date2030-10-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Hernia
Hernia, Ventral
Hernia, Abdominal
Hernia Abdominal Wall