Miromatrix Biological Mesh for Ventral Hernia Repair



Status:Withdrawn
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:10/5/2017
Start Date:June 2015
End Date:April 2016

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A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair

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

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.

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
We found this trial at
4
sites
Hershey, Pennsylvania 17033
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Hershey, PA
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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mi
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Sarasota, FL
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