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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
April 29, 2011
May 3, 2011
July 24, 2017
April 1, 2011
February 1, 2012   (Final data collection date for primary outcome measure)
Pain scores on visual analog scale [ Time Frame: Day 1 ]
Same as current
Complete list of historical versions of study NCT01346332 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Healthy Volunteer Study
Performance of the Iontophoresis System With Headset in Healthy Volunteers
The study will recruit healthy volunteers to undergo the iontophoresis procedure using the Acclarent Iontophoresis System with Headset.
Not Provided
Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Anesthesia of Tympanic Membrane
Device: Iontophoresis System with Headset
Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset
Anesthetization
Intervention: Device: Iontophoresis System with Headset
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
February 1, 2012
February 1, 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01346332
CPR005021
No
Not Provided
Not Provided
Acclarent
Acclarent
Not Provided
Principal Investigator: Joseph Roberson, MD CEI Medical Group
Acclarent
July 2017