Healthy Volunteer Study

Completed

• Conditions: Anesthesia of Tympanic Membrane
• Interventions: Device: Iontophoresis System with Headset

• Registration Number: NCT01346332
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-01
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-05-02
• Study First Posted: 2011-05-03
• Primary Completion: 2012-02-01
• Study Completion: 2012-02-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anesthetization	Iontophoresis System with Headset	-

Primary Outcome Measures

Name	Time	Method
Pain scores on visual analog scale	Day 1

Trial Locations

Locations (1)

CEI Medical Group; 🇺🇸 East Palo Alto, California, United States