Miromatrix Biological Mesh for Hiatal Hernia Repair

Study Overview
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Brief Summary
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Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. 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 hiatal hernia repair.

Official Title
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A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Hiatal Hernia Repair

Conditions
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Hiatal Hernia

Intervention / Treatment
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* Device: MIROMESH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 18 and 80 years old on the day of study enrollment able and willing to sign the consent form and comply with all study visits and procedures able to undergo elective laparoscopic hiatal hernia repair free of cognitive or speech impairment documented, symptomatic type II or III hernia ≥5cm in the axial/vertical dimension commit to non-smoking for at least 4 weeks prior to procedure Exclusion Criteria: previous operation of the esophagus or stomach sensitivity to porcine material pregnant or plan to be pregnant within next 2 years 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 require emergent operation for acute gastric volvulus or strangulation American Society of Anesthesiology (ASA) class 4 or greater BMI ≥40 life expectancy of less than 2 years at the time of enrollment associated gastrointestinal disease that requires extensive medical or surgical intervention that might interfere with the quality of life assessment (e.g. Crohn's disease) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MIROMESH<br>Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias. | Device: MIROMESH<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With a Hernia Recurrence Requiring Reoperation | Failure of the index hernia operation which requires another operative procedure to correct. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus. | 2 years |