Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-06-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MIROMESH
Single-arm study. MIROMESH will be used in the surgical repair of ventral hernia.
MIROMESH®
Interventions
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MIROMESH®
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Miromatrix Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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J. Scott Roth, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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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
Countries
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Other Identifiers
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2015001
Identifier Type: -
Identifier Source: org_study_id