Status:
COMPLETED
Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Acclarent
Conditions:
Acute Otitis Media
Chronic Otitis Media
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provis...
Eligibility Criteria
Inclusion
- Age 12 months and older
- Both male and female patients eligible
- Patients are indicated for procedures requiring penetration of the tympanic membrane (including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube implant)
Exclusion
- Patients with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type or any component of the drug solution
- Markedly atrophic, retracted, atelectatic or perforated tympanic membrane
- Otitis externa
- Electrically sensitive patients and patients with electrically sensitive support systems (pacemakers, defibrillators, etc.)
- Damaged or denuded skin in the auditory canal
- Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00941993
Start Date
April 1 2008
End Date
January 1 2011
Last Update
July 12 2024
Active Locations (1)
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1
Spartanburg ENT
Spartanburg, South Carolina, United States, 29303