Miromatrix Biological Mesh for Hiatal Hernia Repair

M

Miromatrix Medical

Status

Completed

Conditions

Hiatal Hernia

Treatments

Device: MIROMESH

Study type

Interventional

Funder types

Industry

Identifiers

NCT02436681
2015002

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

MIROMESH
Other group
Description:
Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias.
Treatment:
Device: MIROMESH

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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