Healthy Volunteer Study (IPSHS)

Integra LifeSciences

Status: Completed

Conditions: Anesthesia of Tympanic Membrane

Treatments: Device: Iontophoresis System with Headset

Study type: Observational

Funder types: Industry

Identifiers

NCT01346332

CPR005021

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

106 participants in 1 patient group

Anesthetization

Treatment:

Device: Iontophoresis System with Headset