Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Tympanic Membrane Perforation
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects with dry tympanic membrane perforation of at least 6 months duration
    2. Any person of child-bearing potential, must have a negative beta-HCG test and must agree to use an adequate form of birth control throughout the clinical trial

You may not be eligible for this study if the following are true:

    1. Active otitis media or chronic otorrhea from the middle ear
    2. Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents, or chemotherapy
    3. Subjects who, at study entry, are taking systemic antibiotics
    4. Subjects who are immunosuppressed
    5. Subjects experiencing bacterial or viral infection or who may otherwise be febrile or may be with inflammation
    6. Life expectancy of less than 1 year
    7. Active alcohol or drug abuse within 6 months prior to study entry
    8. Significant medical condition that could prevent full participation in the procedures required for the study
    9. Known or suspected allergies to any components used in the study, i.e. porcine collagen
    10. Subjects who have cholesteatoma mass, or endothelium invasion in the tympanic cavity
    11. Subjects whose total perforation cannot be seen by an endoscope
    12. Subjects with inadequately controlled diabetes mellitus
    13. Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility
    14. Subjects who have undergone prior myringoplasty or tympanoplasty
    15. Subjects whose TMP is a result of thermal burn, or radiation therapy.
    16. Subjects who have abnormalities in the auditory ossicles or their linkages
    17. Subjects having moderate to severe dementia such as Alzheimer’s disease or senile dementia
    18. Subjects whose hearing ability does not improve to bone-conduction hearing on a hearing acuity test using the tentative closure of perforation with a wet cotton ball
    19. Subject having residual TM with abnormal form or abnormal shape anatomically
    20. Subjects having any granulation or soft tissue density due to inflammation, or infection in mastoid antrum determined by CT scanning (Temporal bone CT scanning)



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