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Healthy Volunteer Study (IPSHS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01346332
First Posted: May 3, 2011
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Acclarent
  Purpose
The study will recruit healthy volunteers to undergo the iontophoresis procedure using the Acclarent Iontophoresis System with Headset.

Condition Intervention
Anesthesia of Tympanic Membrane Device: Iontophoresis System with Headset

Study Type: Observational
Official Title: Performance of the Iontophoresis System With Headset in Healthy Volunteers

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Pain scores on visual analog scale [ Time Frame: Day 1 ]

Enrollment: 106
Actual Study Start Date: April 1, 2011
Study Completion Date: February 1, 2012
Primary Completion Date: February 1, 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anesthetization Device: Iontophoresis System with Headset
Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 2 years old

Exclusion Criteria:

  • Pregnant or lactating females
  • Subject with a history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution
  • Significant atrophic or perforated tympanic membrane
  • Otitis externa
  • Damaged or denuded skin in the auditory canal
  • Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
  • 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
  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): NCT01346332


Locations
United States, California
CEI Medical Group
East Palo Alto, California, United States, 94303
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Joseph Roberson, MD CEI Medical Group
  More Information

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01346332     History of Changes
Other Study ID Numbers: CPR005021
First Submitted: April 29, 2011
First Posted: May 3, 2011
Last Update Posted: July 24, 2017
Last Verified: July 2017