Ventral HerniaMIROMESH PM-1NCT02408458
Miromatrix Biological Mesh for Ventral Hernia Repair
A study testing MIROMESH® in people with Ventral Hernia, run by Miromatrix Medical Inc. at 4 sites in United States.
Trial summary
This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- MIROMESH®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Kentucky
Lexington, Kentucky, 40536
University of Wisconsin
Madison, Wisconsin, 53792
Sarasota Memorial Hospital
Sarasota, Florida, 34239
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- MIROMESH®
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIROMESH®Device
| Study group | Role | What they receive |
|---|---|---|
| MIROMESH | Other | Single-arm study. MIROMESH will be used in the surgical repair of ventral hernia. Receives: Device: MIROMESH® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence requiring surgical intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miromatrix Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Scott Roth, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408458
- Sponsor's protocol ID
- 2015001
- Acronym
- MIROMESH PM-1
- Status last verified
- Oct 2017
- First submitted
- 26 Mar 2015
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT02408458
- Acronym / sponsor ID
- MIROMESH PM-1 / 2015001
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: enrollment rate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Miromatrix Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIROMESH | Other | Device: MIROMESH®Single-arm study. MIROMESH will be used in the surgical repair of ventral hernia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIROMESH® | Device | MIROMESH |
Primary outcome
Hernia recurrence requiring surgical intervention
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Scott Roth, M.D. principal investigator
University of Kentucky
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIROMESH® in people with Ventral Hernia, run by Miromatrix Medical Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence requiring surgical intervention (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.