Miromatrix Biological Mesh for Ventral Hernia Repair
- Conditions
- Ventral Hernia
- Interventions
- Device: MIROMESH®
- Registration Number
- NCT02408458
- Lead Sponsor
- Miromatrix Medical Inc.
- Brief Summary
This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.
- Detailed Description
Miromatrix Medical Inc. has developed a new biologic mesh, called MIROMESH®. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. Miromatrix Biologic Mesh is a non cross-linked, acellular surgical mesh that is derived from the highly vascularized porcine liver. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for ventral hernia repair.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- between 18 and 80 years old on the day of study enrollment
- ventral or incisional hernia greater than 9 cm2 for which the physician anticipates ability to achieve midline fascia closure following a retro-rectus repair/component separation
- hernia classified as CDC class 1 or 2 preoperatively
- able and willing to sign the consent form and comply with all study visits and procedures
- commit to non-smoking for at least 4 weeks prior to procedure
- sensitivity to porcine material
- scheduled for a concomitant procedure of a wound classified as other than clean
- immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator
- BMI ≥40
- A1C level ≥10.0
- participating in another clinical study
- cirrhosis, and/or ascites
- diagnosed with a collagen vascular disorder
- American Society of Anesthesiology (ASA) Class 4 or 5
- allergic to tetracycline or kanacmycin
- life expectancy of less than 2 years at the time of enrollment
- any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MIROMESH MIROMESH® Single-arm study. MIROMESH will be used in the surgical repair of ventral hernia.
- Primary Outcome Measures
Name Time Method Hernia recurrence requiring surgical intervention 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States