Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02408458
Status:
WITHDRAWN
Last Update Posted:
2017-10-03
First Post:
2015-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Miromatrix Biological Mesh for Ventral Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'enrollment rate', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-02', 'studyFirstSubmitDate': '2015-03-26', 'studyFirstSubmitQcDate': '2015-03-31', 'lastUpdatePostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hernia recurrence requiring surgical intervention', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ventral Hernia']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18 and 80 years old on the day of study enrollment\n* 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\n* hernia classified as CDC class 1 or 2 preoperatively\n* able and willing to sign the consent form and comply with all study visits and procedures\n* commit to non-smoking for at least 4 weeks prior to procedure\n\nExclusion Criteria:\n\n* sensitivity to porcine material\n* scheduled for a concomitant procedure of a wound classified as other than clean\n* 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\n* BMI ≥40\n* A1C level ≥10.0\n* participating in another clinical study\n* cirrhosis, and/or ascites\n* diagnosed with a collagen vascular disorder\n* American Society of Anesthesiology (ASA) Class 4 or 5\n* allergic to tetracycline or kanacmycin\n* life expectancy of less than 2 years at the time of enrollment\n* 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'}, 'identificationModule': {'nctId': 'NCT02408458', 'acronym': 'MIROMESH PM-1', 'briefTitle': 'Miromatrix Biological Mesh for Ventral Hernia Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Miromatrix Medical Inc.'}, 'officialTitle': 'A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair', 'orgStudyIdInfo': {'id': '2015001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MIROMESH', 'description': 'Single-arm study. MIROMESH will be used in the surgical repair of ventral hernia.', 'interventionNames': ['Device: MIROMESH®']}], 'interventions': [{'name': 'MIROMESH®', 'type': 'DEVICE', 'armGroupLabels': ['MIROMESH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Memorial Hospital', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'J. Scott Roth, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miromatrix Medical Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}