Clinical Trial: Miromatrix Biological Mesh for Hiatal Hernia Repair

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Miromatrix Medical Inc.

Current Primary Outcome: Hernia recurrence requiring reoperation [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Miromatrix Medical Inc.

Dates:
Date Received: May 4, 2015
Date Started: August 2015
Date Completion: December 2017
Last Updated: April 7, 2016
Last Verified: April 2016