Healthy Volunteer Study



Status:Completed
Conditions:Other Indications, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:2 - Any
Updated:5/3/2014
Start Date:April 2011
End Date:September 2011
Contact:R Kehl Sink
Email:rsink@its.jnj.com
Phone:650-687-4820

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Trial Summary
Trial Overview
Inclusion Criteria

Performance of the Iontophoresis System With Headset in Healthy Volunteers

The study will recruit healthy volunteers to undergo the iontophoresis procedure using the
Acclarent Iontophoresis System with Headset.


Inclusion Criteria:

- At least 2 years old

Exclusion Criteria:

- Pregnant or lactating females

- Subject with a history of sensitivity or reaction to lidocaine, tetracaine,
epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any
component of the drug solution

- Significant atrophic or perforated tympanic membrane

- Otitis externa

- Damaged or denuded skin in the auditory canal

- Electrically sensitive subjects and subjects with electrically sensitive support
systems (pagemakers, defibrillators, etc.)

- Cerumen impaction resulting in a significant amount of cleaning required to visualize
the tympanic membrane

- Evidence of Otitis Media at day of procedure, or within the past three (3) months
prior to procedure
We found this trial at
1
site
CEI Medical Group
East Palo Alto, California 94303
?
mi
from
East Palo Alto, CA
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