Healthy Volunteer Study

Integra LifeSciences Corporation106 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

106

Conditions

Anesthesia of Tympanic Membrane

Interventions

Iontophoresis System with HeadsetDEVICE

Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset

Eligibility

Sex: ALLMin age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (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

Locations (1)

CEI Medical Group

East Palo Alto, California, United States

Outcomes

Primary Outcomes

Pain scores on visual analog scale

Time frame: Day 1

Data from ClinicalTrials.gov

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