Miromatrix Biological Mesh for Hiatal Hernia Repair

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.

Study Overview

• Status: Completed
• Conditions: Hiatal Hernia
• Intervention / Treatment: Device: MIROMESH

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • New Jersey
    • Long Branch, New Jersey, United States, 07740
      • Monmouth Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Healthcare System
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Virginia
    • Lorton, Virginia, United States, 22079
      • Virginia Heartburn and Hernia Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MIROMESH; Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias.	Device: MIROMESH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With a Hernia Recurrence Requiring Reoperation	Failure of the index hernia operation which requires another operative procedure to correct. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Recurrence	Reports the number of radiographic recurrence of hernia that does not require surgery and are generally asymptomatic. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.	2 years
GERD-HRQL	The Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) scale assess on symptoms associated with gastroesophageal reflux disease. There are 10 questions (each representing a GERD symptom such as heartburn) answered on a 6-point scale of 0 - 6 with 0 indicating no symptoms and 5 indicating incapacitating symptoms. The answer to all questions are summed to give you a final score on the scale. Scores may range for 0 (no symptoms) to 50 (incapacitating symptoms).	2 years
GERD-HRQL Global Assessment	Same as baseline	2 years
SF36 - Physical Component Summary Score	Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.	2 years
SF36 - Mental Component Summary Score	Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.	2 years
SF36 - Physical Functioning	Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Functioning which assess aspects of physical health. The higher the score the better the subject's physical health. Range from 0-100.	2 years
SF36 - Social Functioning	Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Social Functioning which assess aspects of mental health. The higher the score the better the subject's physical health. Range from 0-100.	2 years

Collaborators and Investigators

• Sponsor: Miromatrix Medical Inc.
• Investigators: Principal Investigator: Michael Rosen, M.D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: May 4, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Internal Hernia; Hernia; Hernia, Hiatal
• Other Study ID Numbers: 2015002