Earset Healthy Volunteer Study

Integra LifeSciences Corporation22 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Otitis Media

Interventions

Iontophoresis System With EarsetDEVICE

iontophoresis of lidocaine-based solution for numbing tympanic membrane

Eligibility

Sex: ALLMin age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CEI Medical Group

East Palo Alto, California, United States

Outcomes

Primary Outcomes

Number of subjects anesthetized as assessed by Wong-Baker scale

Time frame: Day 1

Secondary Outcomes

Number of participants with serious adverse events

Time frame: Day 1

Data from ClinicalTrials.gov

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