Anesthetizing the Tympanic Membrane in Healthy Volunteers

Integra LifeSciences

Status: Completed

Conditions: Evaluate Performance and Reliability of Iontophoresis System

Treatments: Device: Acclarent Iontophoresis System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01047904

CPR005006

Details and patient eligibility

About

The study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. >=18 years of age
2. Both male and female subjects are eligible.

Exclusion criteria

1. Pregnant or lactating females
2. Subjects with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution.
3. Markedly atrophic TM
4. Perforated TM
5. Sclerotic TM
6. Otitis externa
7. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
8. Damaged or denuded skin in the auditory canal
9. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
10. Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Iontophoresis-treated

Experimental group

Description:

Healthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM.

Treatment:

Device: Acclarent Iontophoresis System