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Healthy Volunteer Study (IPSHS)

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ClinicalTrials.gov Identifier: NCT01346332
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Acclarent

Brief Summary:
The study will recruit healthy volunteers to undergo the iontophoresis procedure using the Acclarent Iontophoresis System with Headset.

Condition or disease Intervention/treatment
Anesthesia of Tympanic Membrane Device: Iontophoresis System with Headset

Study Type : Observational
Actual Enrollment : 106 participants
Official Title: Performance of the Iontophoresis System With Headset in Healthy Volunteers
Actual Study Start Date : April 1, 2011
Actual Primary Completion Date : February 1, 2012
Actual Study Completion Date : February 1, 2012

Group/Cohort Intervention/treatment
Anesthetization Device: Iontophoresis System with Headset
Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset




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


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
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

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

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