At a glance
ClinicalIndex Comparison RecordN/ACompleted· 42 enrolled
Drug / intervention
Tympanostomy tube placement (Acclarent iontophoresis device)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.
A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office
In Brief
A clinical study evaluating Tympanostomy tube placement (Acclarent iontophoresis device) for Otitis Media. Completed, enrolled 42 participants across 1 site.
Detailed Summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media
CountriesUnited States
CollaboratorsAcclarent
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartOct 2011
Primary CompletionMay 2012
Study CompletionJun 2012
TodayJul 2026
First PostedSep 30, 2011
Enrollment StartOct 1, 2011
Primary CompletionMay 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.8 years ago
Interventions
Tympanostomy tube placement (Acclarent iontophoresis device)device
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device