This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Anesthetizing the Tympanic Membrane in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
Acclarent Identifier:
First received: January 11, 2010
Last updated: March 6, 2014
Last verified: March 2014
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.

Condition Intervention Phase
Evaluate Performance and Reliability of Iontophoresis System Device: Acclarent Iontophoresis System Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 21
Study Start Date: August 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iontophoresis-treated
Healthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM.
Device: Acclarent Iontophoresis System
Administration of local anesthesia using the Acclarent Iontophoresis System


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01047904

United States, California
East Palo Alto, California, United States, 94303
Sponsors and Collaborators
  More Information

Responsible Party: Acclarent Identifier: NCT01047904     History of Changes
Other Study ID Numbers: CPR005006
Study First Received: January 11, 2010
Last Updated: March 6, 2014 processed this record on August 16, 2017