NCT00941993

Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus

First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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 provision of tympanic membrane anesthesia in patients who are indicated for an ear procedure requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.

Conditions

• Acute Otitis Media
• Chronic Otitis Media
• Recurrent Acute Otitis Media

Interventions

Type	Name	Description
DEVICE	Iontophoresis System (Acclarent)	Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-07-20
• Last updated: 2024-07-12
• Results posted: 2014-08-04

Locations

1 site across 1 country: United States