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Miromatrix Biological Mesh for Hiatal Hernia Repair
NCT02436681 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE MIROMESH
Study Locations (6)
Kentucky
- University of Kentucky — Lexington
New Jersey
- Monmouth Medical Center — Long Branch
North Carolina
- Carolinas Healthcare System — Charlotte
Ohio
- Cleveland Clinic — Cleveland
Virginia
- Virginia Heartburn and Hernia Institute — Lorton
Wisconsin
- Medical College of Wisconsin — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-08 |
| Est. Completion | 2018-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02436681
The ClinicalTrials.gov registry entry for NCT02436681 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Miromatrix Medical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hiatal Hernia appearing as the primary indexed condition, and to 1 intervention — of which MIROMESH is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02436681 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Kentucky, New Jersey, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02436681 about?
NCT02436681 is a clinical study titled "Miromatrix Biological Mesh for Hiatal Hernia Repair". 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 clinicia...
What is the current status of trial NCT02436681?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2015-08. Estimated completion is 2018-07.
What conditions does trial NCT02436681 study?
This clinical trial studies the following conditions: Hiatal Hernia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02436681?
The interventions under investigation include: MIROMESH (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02436681?
This trial is sponsored by Miromatrix Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02436681 being conducted?
This trial has 6 study locations across Kentucky, New Jersey, North Carolina, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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