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Completed

NCT Number: NCT01611246

Earset Healthy Volunteer Study

The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

12 month 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 12 months old

Exclusion criteria

  • Pregnant or lactating females
  • Subjects with 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
  • Significantly 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 Earset

Device

iontophoresis of lidocaine-based solution for numbing tympanic membrane

Primary outcomes

  1. Number of subjects anesthetized as assessed by Wong-Baker scale

    Time frame: Day 1

Secondary outcomes

  1. Number of participants with serious adverse events

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Official study title

Performance of the Acclarent Iontophoresis System With Earset (IPSES) in Healthy Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 4, 2012
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.

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