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NCT01611246 Clinical Trial

Earset Healthy Volunteer Study

Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01611246
Other study ID # CPR005031
Secondary ID
Status Completed
Phase N/A
First received May 29, 2012
Last updated July 21, 2017
Start date May 1, 2012
Est. completion date August 1, 2012

Study information
Verified date July 2017
Source Acclarent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date August 1, 2012
Est. primary completion date August 1, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Iontophoresis System With Earset
iontophoresis of lidocaine-based solution for numbing tympanic membrane

Locations
Country Name City State
United States CEI Medical Group East Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of subjects anesthetized as assessed by Wong-Baker scale Day 1
Secondary Number of participants with serious adverse events Day 1
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