At a glance
ClinicalIndex Comparison RecordN/ACompleted· 50 enrolled
Drug / intervention
MIROMESHdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Hiatal Hernia Repair
In Brief
A clinical study evaluating MIROMESH for Hiatal Hernia. Completed, enrolled 50 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHiatal Hernia
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartAug 2015
Primary CompletionJul 2018
TodayJul 2026
First PostedMay 7, 2015
Enrollment StartAug 1, 2015
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.2 years ago
Interventions
MIROMESHdevice