Miromatrix Biological Mesh for Ventral Hernia Repair

Withdrawn before enrolling · Not applicable

Conditions studied: Ventral Hernia

In brief

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

Key facts

Study ID

NCT02408458

Run by

Miromatrix Medical Inc.

People needed

0

Starts

2015-06-01

Expected to finish

2016-04-01

Last updated by the study team

2017-10-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sarasota Memorial Hospital — Sarasota, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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