Healthy Volunteer Study

Performance of the Iontophoresis System With Headset in Healthy Volunteers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01346332

Acronym

IPSHS

Enrollment

106

Registered

2011-05-03

Start date

2011-04-01

Completion date

2012-02-01

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

Anesthesia of Tympanic Membrane

Brief summary

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

Interventions

DEVICEIontophoresis System with Headset

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

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pain scores on visual analog scale	Day 1

Countries

United States

Outcome results

None listed

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