Miromatrix Biological Mesh for Hiatal Hernia Repair

Hiatal Hernia Clinical Trial

Official title:

A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Hiatal Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436681
• Other study ID #: 2015002
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 2018

Study information

• Verified date: September 2019
• Source: Miromatrix Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Hiatal Hernia

Intervention

Device:
• MIROMESH

Locations

Country	Name	City	State
United States	Carolinas Healthcare System	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Kentucky	Lexington	Kentucky
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Virginia Heartburn and Hernia Institute	Lorton	Virginia
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Miromatrix Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	GERD-HRQL Global Assessment	Same as baseline	2 years
Other	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
Other	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
Other	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
Other	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
Primary	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