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Healthy Volunteer Study (IPSHS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Acclarent.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Acclarent
ClinicalTrials.gov Identifier:
NCT01346332
First received: April 29, 2011
Last updated: May 9, 2011
Last verified: May 2011
History of Changes
  Purpose

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


Condition Intervention
Otitis Media
 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

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

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 ]

Estimated Enrollment: 20
Study Start Date: April 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: May 2011 (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 (pagemakers, 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

Contacts
Contact: R Kehl Sink 650-687-4820 rsink@its.jnj.com
Contact: Patricia Chen 650-687-4451 pchen126@its.jnj.com

Locations
United States, California
CEI Medical Group Recruiting
East Palo Alto, California, United States, 94303
Contact: Joseph Roberson, MD     650-494-1000     jbr@calear.com    
Contact: R Kehl Sink     650-687-4820     rsink@its.jnj.com    
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Joseph Roberson, MD CEI Medical Group
  More Information

No publications provided

Responsible Party: R. Kehl Sink, Acclarent, Inc.
ClinicalTrials.gov Identifier: NCT01346332     History of Changes
Other Study ID Numbers: CPR005021
Study First Received: April 29, 2011
Last Updated: May 9, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013