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

Primary Purpose

Ventral Hernia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIROMESH®
Sponsored by
Miromatrix Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sarasota Memorial Hospital
  • University of Kentucky
  • Penn State Hershey Medical Center
  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MIROMESH

Arm Description

Single-arm study. MIROMESH will be used in the surgical repair of ventral hernia.

Outcomes

Primary Outcome Measures

Hernia recurrence requiring surgical intervention

Secondary Outcome Measures

Full Information

First Posted
March 26, 2015
Last Updated
October 2, 2017
Sponsor
Miromatrix Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02408458
Brief Title
Miromatrix Biological Mesh for Ventral Hernia Repair
Acronym
MIROMESH PM-1
Official Title
A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
enrollment rate
Study Start Date
June 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Miromatrix Medical Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIROMESH
Arm Type
Other
Arm Description
Single-arm study. MIROMESH will be used in the surgical repair of ventral hernia.
Intervention Type
Device
Intervention Name(s)
MIROMESH®
Primary Outcome Measure Information:
Title
Hernia recurrence requiring surgical intervention
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Scott Roth, M.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Miromatrix Biological Mesh for Ventral Hernia Repair

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