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
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, see Learn About Clinical Studies.

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 September 30, 2014