Overview

This trial is active, not recruiting.

Condition hiatal hernia
Treatment miromesh
Sponsor Miromatrix Medical Inc.
Start date August 2015
End date December 2017
Trial size 50 participants
Trial identifier NCT02436681, 2015002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias.
miromesh

Primary Outcomes

Measure
Hernia recurrence requiring reoperation
time frame: 2 years

Eligibility Criteria

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

Additional Information

Official title A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Hiatal Hernia Repair
Principal investigator Michael Rosen, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Miromatrix Medical Inc..