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CompletedNCT01611246Updated Jul 11, 2024

Earset Healthy Volunteer Study

An observational study in Otitis Media, sponsored by Integra LifeSciences Corporation. Completed at 1 site in United States. Open to participants aged 12 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-11.

Sponsored by Integra LifeSciences Corporation · Observational

Study type
Observational
Enrollment
22
Ages
12 Months and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Otitis Media

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03

In context

Otitis Media

284 studies on the registry are indexed under Otitis Media; 33 are open to participants now.

This study's enrollment of 22 is below the median of 155 across 72 observational studies indexed under Otitis Media.

Browse Otitis Media studies →

Lead sponsor

Integra LifeSciences Corporation is the lead sponsor of 81 studies on the registry; 5 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • At least 12 months old

Exclusion criteria

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.
05

Study design

Enrollment
22 participants (actual)

Groups and cohorts

  • Anesthetization

    Anesthetization

    Device: Iontophoresis System With Earset

Interventions

  • DeviceIontophoresis System With Earset

    iontophoresis of lidocaine-based solution for numbing tympanic membrane

06

What researchers measure

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

07

Study locations

1 site
  • CEI Medical Group
    East Palo Alto, California 94303, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01611246
Lead sponsor
Integra LifeSciences Corporation
Collaborators
Acclarent
Responsible party
Sponsor
First posted
Jun 4, 2012
Start date
May 1, 2012
Primary completion
Aug 1, 2012
Completion
Aug 1, 2012
Last update
Jul 11, 2024

Study contacts

Joseph Roberson, M.D.
principal investigator · CEI Medical Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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