Earset Healthy Volunteer Study
Completed
- Conditions
- Otitis Media
- Interventions
- Device: Iontophoresis System With Earset
- Registration Number
- NCT01611246
- Lead Sponsor
- Integra LifeSciences Corporation
- Brief Summary
The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Anesthetization Iontophoresis System With Earset Anesthetization
- Primary Outcome Measures
Name Time Method Number of subjects anesthetized as assessed by Wong-Baker scale Day 1
- Secondary Outcome Measures
Name Time Method Number of participants with serious adverse events Day 1
Trial Locations
- Locations (1)
CEI Medical Group
🇺🇸East Palo Alto, California, United States