Miromatrix Biological Mesh for Hiatal Hernia Repair
Primary Purpose
Hiatal Hernia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIROMESH
Sponsored by
About this trial
This is an interventional treatment trial for Hiatal Hernia
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
Sites / Locations
- University of Kentucky
- Monmouth Medical Center
- Carolinas Healthcare System
- Cleveland Clinic
- Virginia Heartburn and Hernia Institute
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MIROMESH
Arm Description
Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02436681
First Posted
May 4, 2015
Last Updated
September 18, 2019
Sponsor
Miromatrix Medical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02436681
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Miromatrix Medical Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiatal Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MIROMESH
Arm Type
Other
Arm Description
Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias.
Intervention Type
Device
Intervention Name(s)
MIROMESH
Primary Outcome Measure Information:
Title
Number of Subjects With a Hernia Recurrence Requiring Reoperation
Description
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.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Radiographic Recurrence
Description
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.
Time Frame
2 years
Title
GERD-HRQL
Description
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).
Time Frame
2 years
Title
GERD-HRQL Global Assessment
Description
Same as baseline
Time Frame
2 years
Title
SF36 - Physical Component Summary Score
Description
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.
Time Frame
2 years
Title
SF36 - Mental Component Summary Score
Description
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.
Time Frame
2 years
Title
SF36 - Physical Functioning
Description
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.
Time Frame
2 years
Title
SF36 - Social Functioning
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rosen, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
Carolinas Healthcare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Virginia Heartburn and Hernia Institute
City
Lorton
State/Province
Virginia
ZIP/Postal Code
22079
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
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Miromatrix Biological Mesh for Hiatal Hernia Repair
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