Study Stopped
enrollment rate
Miromatrix Biological Mesh for Ventral Hernia Repair
MIROMESH PM-1
A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair
1 other identifier
interventional
N/A
1 country
4
Brief Summary
This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2015
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
April 3, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedOctober 3, 2017
October 1, 2017
10 months
March 26, 2015
October 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hernia recurrence requiring surgical intervention
1 year
Study Arms (1)
MIROMESH
OTHERSingle-arm study. MIROMESH will be used in the surgical repair of ventral hernia.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Scott Roth, M.D.
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
April 3, 2015
Study Start
June 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
October 3, 2017
Record last verified: 2017-10