Anesthetizing the Tympanic Membrane in Healthy Volunteers

Not Applicable

Completed

• Conditions: Evaluate Performance and Reliability of Iontophoresis System
• Interventions: Device: Acclarent Iontophoresis System

• Registration Number: NCT01047904
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iontophoresis-treated	Acclarent Iontophoresis System	Healthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM.

Primary Outcome Measures

Name	Time	Method
Procedural Success	X days	Evaluation of the performance and reliability of the Acclarent Iontophoresis System in delivery of local anesthesia to the TM in healthy volunteers

Secondary Outcome Measures

Name	Time	Method
Tolerability of the iontophoresis system	X days	Subject tolerability of the iontophoresis procedure will be assessed using a pain scale
Incidence of adverse effects associated with the System and the Iontophoresis procedure	X days	The investigator will rate any adverse event that occurs during the procedure for level of severity and relationship to the study device.