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Earset Healthy Volunteer Study

Primary Purpose

Otitis Media

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Iontophoresis System With Earset
Sponsored by
Acclarent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Otitis Media

Eligibility Criteria

12 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CEI Medical Group

Arms of the Study

Arm 1

Arm Type

Arm Label

Anesthetization

Arm Description

Anesthetization

Outcomes

Primary Outcome Measures

Number of subjects anesthetized as assessed by Wong-Baker scale

Secondary Outcome Measures

Number of participants with serious adverse events

Full Information

First Posted
May 29, 2012
Last Updated
July 21, 2017
Sponsor
Acclarent
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1. Study Identification

Unique Protocol Identification Number
NCT01611246
Brief Title
Earset Healthy Volunteer Study
Official Title
Performance of the Acclarent Iontophoresis System With Earset (IPSES) in Healthy Volunteers
Study Type
Observational

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2012 (Actual)
Primary Completion Date
August 1, 2012 (Actual)
Study Completion Date
August 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acclarent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media

7. Study Design

Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anesthetization
Arm Description
Anesthetization
Intervention Type
Device
Intervention Name(s)
Iontophoresis System With Earset
Intervention Description
iontophoresis of lidocaine-based solution for numbing tympanic membrane
Primary Outcome Measure Information:
Title
Number of subjects anesthetized as assessed by Wong-Baker scale
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of participants with serious adverse events
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Roberson, M.D.
Organizational Affiliation
CEI Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEI Medical Group
City
East Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States

12. IPD Sharing Statement

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Earset Healthy Volunteer Study

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