Healthy Volunteer Study (IPSHS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01346332
First received: April 29, 2011
Last updated: March 14, 2014
Last verified: March 2014
  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: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01346332     History of Changes
Other Study ID Numbers: CPR005021
Study First Received: April 29, 2011
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 22, 2014