Miromatrix Biological Mesh for Ventral Hernia Repair (MIROMESH PM-1)

October 2, 2017 updated by: Miromatrix Medical Inc.

A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair

This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between 18 and 80 years old on the day of study enrollment
  • ventral or incisional hernia greater than 9 cm2 for which the physician anticipates ability to achieve midline fascia closure following a retro-rectus repair/component separation
  • hernia classified as CDC class 1 or 2 preoperatively
  • able and willing to sign the consent form and comply with all study visits and procedures
  • commit to non-smoking for at least 4 weeks prior to procedure

Exclusion Criteria:

  • sensitivity to porcine material
  • scheduled for a concomitant procedure of a wound classified as other than clean
  • immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator
  • BMI ≥40
  • A1C level ≥10.0
  • participating in another clinical study
  • cirrhosis, and/or ascites
  • diagnosed with a collagen vascular disorder
  • American Society of Anesthesiology (ASA) Class 4 or 5
  • allergic to tetracycline or kanacmycin
  • life expectancy of less than 2 years at the time of enrollment
  • any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MIROMESH
Single-arm study. MIROMESH will be used in the surgical repair of ventral hernia.
Device: MIROMESH®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hernia recurrence requiring surgical intervention
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miromatrix Medical Inc.

Investigators

  • Principal Investigator: J. Scott Roth, M.D., University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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