Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02408458
Status:
WITHDRAWN
Last Update Posted:
2017-10-03
First Post:
2015-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Miromatrix Biological Mesh for Ventral Hernia Repair
Sponsor:
Miromatrix Medical Inc.
Organization:
Study Overview
Official Title:
A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair
Status:
WITHDRAWN
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrollment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIROMESH PM-1
Brief Summary:
This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.
Detailed Description:
Miromatrix Medical Inc. has developed a new biologic mesh, called MIROMESH®. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. Miromatrix Biologic Mesh is a non cross-linked, acellular surgical mesh that is derived from the highly vascularized porcine liver. 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 ventral hernia repair.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: