Miromatrix Biological Mesh for Hiatal Hernia Repair

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hiatal Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MIROMESH

Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias.

Group Type OTHER

MIROMESH

Intervention Type DEVICE

Interventions

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MIROMESH

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No