Earset Healthy Volunteer Study

Performance of the Acclarent Iontophoresis System With Earset (IPSES) in Healthy Volunteers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01611246

Enrollment

Registered

2012-06-04

Start date

2012-05-01

Completion date

2012-08-01

Last updated

2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media

Brief summary

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

Interventions

DEVICEIontophoresis System With Earset

iontophoresis of lidocaine-based solution for numbing tympanic membrane

Eligibility

Sex/Gender

ALL

Age

12 Months to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of subjects anesthetized as assessed by Wong-Baker scale	Day 1

Secondary

Measure	Time frame
Number of participants with serious adverse events	Day 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026