Clinical trial NCT02436681: Miromatrix Biological Mesh for Hiatal Hernia Repair
Official title: A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Hiatal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiatal Hernia
Lead sponsor: Miromatrix Medical Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Subjects With a Hernia Recurrence Requiring Reoperation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: Radiographic Recurrence
timeFrame: 2 years
measure: GERD-HRQL
timeFrame: 2 years
measure: GERD-HRQL Global Assessment
timeFrame: 2 years
measure: SF36 - Physical Component Summary Score
timeFrame: 2 years
measure: SF36 - Mental Component Summary Score
timeFrame: 2 years
measure: SF36 - Physical Functioning
timeFrame: 2 years
measure: SF36 - Social Functioning
timeFrame: 2 years
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Lorton
country: United States
facility: Virginia Heartburn and Hernia Institute
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: Michael Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: