Healthy Volunteer Study

Anesthesia of Tympanic Membrane Clinical Trial

— IPSHS  

Official title:

Performance of the Iontophoresis System With Headset in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346332
• Other study ID #: CPR005021
• Status: Completed
• Phase: N/A
• First received: April 29, 2011
• Last updated: July 21, 2017
• Start date: April 1, 2011
• Est. completion date: February 1, 2012

Study information

• Verified date: July 2017
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 1, 2012
• Est. primary completion date: February 1, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia of Tympanic Membrane

Intervention

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

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	Pain scores on visual analog scale		Day 1