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Anesthetizing the Tympanic Membrane in Healthy Volunteers - NCT01047904-94303(Clinical Trial 464850)



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City:  East Palo Alto
State:  
CA
Zip Code: 94303
Conditions: Otitis Media
Purpose: The study objective is to evaluate the performance and reliability of minor design changes to the system components. Data collected from this study will enable the development of future applications and technology.
Study summary: The study will recruit healthy volunteers to undergo the Ioontophoresis procedure using the existing and/or modified System components. Data collected in the study will enable evaluation of design modifications that are independent of TM health.
Criteria: Inclusion Criteria: 1. >=18 years of age 2. Both male and female subjects are eligible. Exclusion Criteria: 1. Pregnant or lactating females 2. Subjects with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution. 3. Markedly atrophic TM 4. Perforated TM 5. Sclerotic TM 6. Otitis externa 7. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.) 8. Damaged or denuded skin in the auditory canal 9. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane 10. Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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