Anesthetizing the Tympanic Membrane in Healthy Volunteers

Integra LifeSciences Corporation21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Evaluate Performance and Reliability of Iontophoresis System

Interventions

Acclarent Iontophoresis SystemDEVICE

Administration of local anesthesia using the Acclarent Iontophoresis System

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

East Palo Alto, California, United States

Outcomes

Primary Outcomes

Procedural Success

Evaluation of the performance and reliability of the Acclarent Iontophoresis System in delivery of local anesthesia to the TM in healthy volunteers

Time frame: X days

Secondary Outcomes

Incidence of adverse effects associated with the System and the Iontophoresis procedure

The investigator will rate any adverse event that occurs during the procedure for level of severity and relationship to the study device.

Time frame: X days

Tolerability of the iontophoresis system

Subject tolerability of the iontophoresis procedure will be assessed using a pain scale

Time frame: X days

Data from ClinicalTrials.gov

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