Performance of the Iontophoresis System With Headset in Healthy Volunteers

Conditions:		Otitis Media
Purpose:		The study will recruit healthy volunteers to undergo the iontophoresis procedure using the Acclarent Iontophoresis System with Headset.
Study Summary:
Criteria:		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
NCT ID:		NCT01346332
Primary Contact:		Principal Investigator Joseph Roberson, MD CEI Medical Group R Kehl Sink Phone: 650-687-4820 Email: rsink@its.jnj.com
Backup Contact:		Email: pchen126@its.jnj.com Patricia Chen Phone: 650-687-4451
Location Contact:		East Palo Alto, California 94303 United States Joseph Roberson, MD Phone: 650-494-1000 Email: jbr@calear.com Site Status: Recruiting

Data Source:		ClinicalTrials.gov
Date Processed:		May 18, 2013
Modifications to this listing:		Only selected fields are shown, please use the link below to view all information about this clinical trial.
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