Earset Healthy Volunteer Study



Status:Completed
Conditions:Other Indications, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any
Updated:5/3/2014
Start Date:May 2012
End Date:June 2013
Contact:Robert K Sink, Ph.D.
Email:rsink@its.jnj.com
Phone:650-687-4820

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Performance of the Acclarent Iontophoresis System With Earset (IPSES) in Healthy Volunteers

The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the
Acclarent Iontophoresis System with Earset (IPSES).


Inclusion Criteria:

- At least 12 months old

Exclusion Criteria:

- Pregnant or lactating females

- Subjects with 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

- Significantly 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 (pacemakers, 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
East Palo Alto, California 94303
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East Palo Alto, CA
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