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 |
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).
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.
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