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OpenTrials
Completed

NCT Number: NCT02436681

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.

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Key information

Conditions

Hiatal Hernia Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky, Lexington, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIROMESH

Device

Primary outcomes

  1. Number of Subjects With a Hernia Recurrence Requiring Reoperation

    Time frame: 2 years

    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.

Other outcomes

  1. Radiographic Recurrence

    Time frame: 2 years

    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. GERD-HRQL

    Time frame: 2 years

    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).

  3. GERD-HRQL Global Assessment

    Time frame: 2 years

    Same as baseline

  4. SF36 - Physical Component Summary Score

    Time frame: 2 years

    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.

  5. SF36 - Mental Component Summary Score

    Time frame: 2 years

    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.

  6. SF36 - Physical Functioning

    Time frame: 2 years

    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.

  7. SF36 - Social Functioning

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Miromatrix Medical Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 7, 2015
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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