Miromatrix Biological Mesh for Ventral Hernia Repair

Ventral Hernia Clinical Trial

— MIROMESH PM-1  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02408458
• Other study ID #: 2015001
• Status: Withdrawn
• Phase: N/A
• First received: March 26, 2015
• Last updated: October 2, 2017
• Start date: June 2015
• Est. completion date: April 2016

Study information

• Verified date: October 2017
• Source: Miromatrix Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• MIROMESH®

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	University of Kentucky	Lexington	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Sarasota Memorial Hospital	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Miromatrix Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence requiring surgical intervention		1 year