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OpenTrials
Completed

NCT Number: NCT01346332

Healthy Volunteer Study

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

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Key information

Conditions

Anesthesia of Tympanic Membrane

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CEI Medical Group

East Palo Alto, California, 94303, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iontophoresis System with Headset

Device

Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset

Primary outcomes

  1. Pain scores on visual analog scale

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Official study title

Performance of the Iontophoresis System With Headset in Healthy Volunteers

Acronym: IPSHS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 3, 2011
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.