Earset Healthy Volunteer Study

Completed

Conditions studied: Otitis Media

In brief

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

Key facts

Study ID

NCT01611246

Run by

Integra LifeSciences Corporation

People needed

22

Starts

2012-05-01

Expected to finish

2012-08-01

Last updated by the study team

2024-07-11

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• At least 12 months old

You may not qualify if…

• 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.

Where it is running

• CEI Medical Group — East Palo Alto, California, United States

Full record on ClinicalTrials.gov

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