Miromatrix Biological Mesh for Ventral Hernia Repair (MIROMESH PM-1)

Miromatrix Medical

Status: Withdrawn

Conditions: Ventral Hernia

Treatments: Device: MIROMESH®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02408458

2015001

Details and patient eligibility

About

This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

MIROMESH

Other group

Description:

Single-arm study. MIROMESH will be used in the surgical repair of ventral hernia.

Treatment:

Device: MIROMESH®