Anesthetizing the Tympanic Membrane in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01047904
First received: January 11, 2010
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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
Other Name: Acclarent Iontophoresis System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01047904

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

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01047904     History of Changes
Other Study ID Numbers: CPR005006
Study First Received: January 11, 2010
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014