Earset Healthy Volunteer Study

Integra LifeSciences

Status: Completed

Conditions: Otitis Media

Treatments: Device: Iontophoresis System With Earset

Study type: Observational

Funder types: Industry

Identifiers

NCT01611246

CPR005031

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 12+ months old

Volunteers: Accepts 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.

Trial design

22 participants in 1 patient group

Anesthetization

Description:

Anesthetization

Treatment:

Device: Iontophoresis System With Earset