Trials / Completed
CompletedNCT02436681
Miromatrix Biological Mesh for Hiatal Hernia Repair
A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Hiatal Hernia Repair
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Miromatrix Medical Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MIROMESH |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2018-07-01
- Completion
- 2018-07-01
- First posted
- 2015-05-07
- Last updated
- 2019-09-20
- Results posted
- 2019-09-18
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02436681. Inclusion in this directory is not an endorsement.