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:
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Conditions: Tympanic Membrane Perforation
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Age: Between 18 Year(s) - 100 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Subjects with dry tympanic membrane perforation of at least 6 months duration
- 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:
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- Active otitis media or chronic otorrhea from the middle ear
- Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents, or chemotherapy
- Subjects who, at study entry, are taking systemic antibiotics
- Subjects who are immunosuppressed
- Subjects experiencing bacterial or viral infection or who may otherwise be febrile or may be with inflammation
- Life expectancy of less than 1 year
- Active alcohol or drug abuse within 6 months prior to study entry
- Significant medical condition that could prevent full participation in the procedures required for the study
- Known or suspected allergies to any components used in the study, i.e. porcine collagen
- Subjects who have cholesteatoma mass, or endothelium invasion in the tympanic cavity
- Subjects whose total perforation cannot be seen by an endoscope
- Subjects with inadequately controlled diabetes mellitus
- Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility
- Subjects who have undergone prior myringoplasty or tympanoplasty
- Subjects whose TMP is a result of thermal burn, or radiation therapy.
- Subjects who have abnormalities in the auditory ossicles or their linkages
- Subjects having moderate to severe dementia such as Alzheimer’s disease or senile dementia
- 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
- Subject having residual TM with abnormal form or abnormal shape anatomically
- Subjects having any granulation or soft tissue density due to inflammation, or infection in mastoid antrum determined by CT scanning (Temporal bone CT scanning)
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.