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Anesthetizing the Tympanic Membrane in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01047904
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : March 10, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Evaluate Performance and Reliability of Iontophoresis System Device: Acclarent Iontophoresis System Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers
Study Start Date : August 2009
Primary Completion Date : November 2009
Study Completion Date : November 2009
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Tolerability of the iontophoresis system [ Time Frame: X days ]
    Subject tolerability of the iontophoresis procedure will be assessed using a pain scale

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047904

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

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01047904     History of Changes
Other Study ID Numbers: CPR005006
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014