Miromatrix Biological Mesh for Hiatal Hernia Repair



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:9/27/2018
Start Date:August 2015
End Date:July 2018

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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.


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
We found this trial at
6
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Charlotte, North Carolina 28203
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Charlotte, NC
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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Long Branch, New Jersey
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Long Branch, NJ
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Lorton, VA
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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