NCT02436681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 18, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

May 4, 2015

Results QC Date

June 17, 2019

Last Update Submit

September 18, 2019

Conditions

Hiatal Hernia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Radiographic Recurrence

    2 years

  • GERD-HRQL

    2 years

  • GERD-HRQL Global Assessment

    2 years

  • +4 more other outcomes

Study Arms (1)

MIROMESH

OTHER

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

Device: MIROMESH

Interventions

MIROMESHDEVICE
MIROMESH

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Carolinas Healthcare System

Charlotte, North Carolina, 28204, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Virginia Heartburn and Hernia Institute

Lorton, Virginia, 22079, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was not a randomized controlled trial, thus direct comparisons to no treatment or other treatment cannot be made.

Results Point of Contact

Title
Head of Clinical Affairs
Organization
Miromatrix
mmacenski@miromatrix.com
952.942-6000

Study Officials

  • Michael Rosen, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 7, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

September 20, 2019

Results First Posted

September 18, 2019

Record last verified: 2019-09

Locations

US(6)