Miromatrix Biological Mesh for Hiatal Hernia Repair
This trial is active, not recruiting.
|Sponsor||Miromatrix Medical Inc.|
|Start date||August 2015|
|End date||December 2017|
|Trial size||50 participants|
|Trial identifier||NCT02436681, 2015002|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Lexington, KY||University of Kentucky||no longer recruiting|
|Long Branch, NJ||Monmouth Medical Center||no longer recruiting|
|Charlotte, NC||Carolinas Healthcare System||no longer recruiting|
|Cleveland, OH||Cleveland Clinic||no longer recruiting|
|Lorton, VA||Virginia Heartburn and Hernia Institute||no longer recruiting|
|Milwaukee, WI||Medical College of Wisconsin||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias.
Hernia recurrence requiring reoperation
time frame: 2 years
Male or female participants from 18 years up to 80 years old.
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
|Official title||A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Hiatal Hernia Repair|
|Principal investigator||Michael Rosen, M.D.|
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