Hiatal HerniaNCT02436681
Miromatrix Biological Mesh for Hiatal Hernia Repair
A study testing MIROMESH in people with Hiatal Hernia, run by Miromatrix Medical Inc. at 6 sites in United States.
Trial summary
Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hiatal 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
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- able and willing to sign the consent form and comply with all study visits and procedures
- able to undergo elective laparoscopic hiatal hernia repair
- free of cognitive or speech impairment
- documented, symptomatic type II or III hernia ≥5cm in the axial/vertical dimension
- commit to non-smoking for at least 4 weeks prior to procedure
Who cannot join
- previous operation of the esophagus or stomach
- sensitivity to porcine material
- pregnant or plan to be pregnant within next 2 years
- 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
- require emergent operation for acute gastric volvulus or strangulation
- American Society of Anesthesiology (ASA) class 4 or greater
Show all 10Show fewer
- BMI ≥40
- life expectancy of less than 2 years at the time of enrollment
- associated gastrointestinal disease that requires extensive medical or surgical intervention that might interfere with the quality of life assessment (e.g. Crohn's disease)
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Carolinas Healthcare System
Charlotte, North Carolina, 28204
Cleveland Clinic
Cleveland, Ohio, 44195
University of Kentucky
Lexington, Kentucky, 40536
Monmouth Medical Center
Long Branch, New Jersey, 07740
Virginia Heartburn and Hernia Institute
Lorton, Virginia, 22079
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Hiatal Hernia Repair
Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. 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 hiatal hernia repair.
- Conditions
- Hiatal Hernia
- Being tested
- MIROMESH
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIROMESHDevice
| Study group | Role | What they receive |
|---|---|---|
| MIROMESH | Other | Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias. Receives: Device: MIROMESH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a Hernia Recurrence Requiring Reoperation
Failure of the index hernia operation which requires another operative procedure to correct. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hiatal 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miromatrix Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Rosen, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436681
- Sponsor's protocol ID
- 2015002
- Status last verified
- Sep 2019
- First submitted
- 4 May 2015
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. 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 Hiatal Hernia Repair
- ClinicalTrials.gov ID
- NCT02436681
- Acronym / sponsor ID
- 2015002
- Conditions
- Hiatal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Miromatrix Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Posted 18 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. 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 hiatal 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: MIROMESHSingle-arm study. MIROMESH will be used in the surgical repair of hiatal hernias. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- between 18 and 80 years old on the day of study enrollment
- able and willing to sign the consent form and comply with all study visits and procedures
- able to undergo elective laparoscopic hiatal hernia repair
- free of cognitive or speech impairment
- documented, symptomatic type II or III hernia ≥5cm in the axial/vertical dimension
Key exclusion criteria (10 listed)
- previous operation of the esophagus or stomach
- sensitivity to porcine material
- pregnant or plan to be pregnant within next 2 years
- 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
- require emergent operation for acute gastric volvulus or strangulation
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
Number of Subjects With a Hernia Recurrence Requiring Reoperation
Time frame: 2 years
Failure of the index hernia operation which requires another operative procedure to correct. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Phrenoesophageal Ligament Reconstruction With Mesh
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Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
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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.
Michael Rosen, M.D. principal investigator
The Cleveland Clinic
6 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 Hiatal Hernia, run by Miromatrix Medical Inc. at 6 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 18 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With a Hernia Recurrence Requiring Reoperation (time frame: 2 years). 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 20 Sep 2019.