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Anesthetizing the Tympanic Membrane in Healthy Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Acclarent.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Acclarent
ClinicalTrials.gov Identifier:
NCT01047904
First received: January 11, 2010
Last updated: May 9, 2011
Last verified: May 2011
History of Changes
  Purpose

The study objective is to evaluate the performance and reliability of minor design changes to the system components. Data collected from this study will enable the development of future applications and technology.


Condition Intervention
Otitis Media
 Device: Acclarent Iontophoresis System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Acute Procedural Success [ Time Frame: Procedural ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse effects associated with the System and the Iontophoresis procedure [ Time Frame: Procedural ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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
Investigators
Principal Investigator: xxx xxx, MD Private Practice
  More Information

No publications provided

Responsible Party: Patricia Chen, Sr. CRA, Acclarent, Inc.
ClinicalTrials.gov Identifier: NCT01047904     History of Changes
Other Study ID Numbers: CPR005006
Study First Received: January 11, 2010
Last Updated: May 9, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013