Anesthetizing the Tympanic Membrane in Healthy Volunteers

Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01047904

Enrollment

Registered

2010-01-13

Start date

2009-08-31

Completion date

2009-11-30

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

Evaluate Performance and Reliability of Iontophoresis System

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.

Interventions

DEVICEAcclarent Iontophoresis System

Administration of local anesthesia using the Acclarent Iontophoresis System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Tolerability of the iontophoresis system	X days	Subject tolerability of the iontophoresis procedure will be assessed using a pain scale

Countries

United States

Outcome results

None listed

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