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Miromatrix Biological Mesh for Hiatal Hernia Repair

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ClinicalTrials.gov Identifier: NCT02436681
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Miromatrix Medical Inc.

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Hiatal Hernia Device: MIROMESH Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Hiatal Hernia Repair
Actual Study Start Date : August 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MIROMESH
Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias.
Device: MIROMESH



Primary Outcome Measures :
  1. Hernia recurrence requiring reoperation [ Time Frame: 2 years ]
    Failure of the index hernia operation which requires another operative procedure to correct



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436681


Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
United States, North Carolina
Carolinas Healthcare System
Charlotte, North Carolina, United States, 28204
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Virginia
Virginia Heartburn and Hernia Institute
Lorton, Virginia, United States, 22079
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Miromatrix Medical Inc.
Investigators
Principal Investigator: Michael Rosen, M.D. The Cleveland Clinic

Responsible Party: Miromatrix Medical Inc.
ClinicalTrials.gov Identifier: NCT02436681     History of Changes
Other Study ID Numbers: 2015002
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: July 2017

Additional relevant MeSH terms:
Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic