East Palo Alto, California, 94303, United States
Completed
NCT Number: NCT01047904
Anesthetizing the Tympanic Membrane in Healthy Volunteers
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- >=18 years of age
- Both male and female subjects are eligible.
Exclusion criteria
- Pregnant or lactating females
- 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.
- Markedly atrophic TM
- Perforated TM
- Sclerotic TM
- Otitis externa
- Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
- Damaged or denuded skin in the auditory canal
- 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.
Treatment and study plan
Acclarent Iontophoresis System
DeviceAdministration of local anesthesia using the Acclarent Iontophoresis System
Primary outcomes
-
Procedural Success
Time frame: 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 outcomes
-
Incidence of adverse effects associated with the System and the Iontophoresis procedure
Time frame: 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
Time frame: X days
Subject tolerability of the iontophoresis procedure will be assessed using a pain scale
Sponsors and collaborators
Lead sponsor
Integra LifeSciences Corporation
Industry
Collaborators
- Acclarent
Registry information
Official study title
Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers
Important dates
- Study start
- 2009
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Jan 13, 2010
- Registry last updated
- Jul 11, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.