CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
Iontophoresis System (Acclarent)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00941993
NCT00941993N/ACompleted
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First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)

Integra LifeSciences Corporation·interventional·Posted Jul 20, 2009·Updated Jul 12, 2024

In Brief

A clinical study evaluating Iontophoresis System (Acclarent) for Acute Otitis Media and 2 related conditions. Completed, enrolled 109 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media, Chronic Otitis Media, Recurrent Acute Otitis Media
CountriesUnited States
CollaboratorsAcclarent

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 20, 2009
Enrollment StartApr 1, 2008
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.9 years ago

Interventions

Iontophoresis System (Acclarent)device

Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.