CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 370 enrolled
Drug / intervention
Iontophoresis & tube placement +1 morecombination
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/NCT03323736
NCT03323736Phase 3Completed
CompareCT.gov

A Prospective, Single-arm, Multicenter Study to Evaluate Effectiveness and Safety of Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Children in an Office Setting.

Tusker Medical·interventional·Posted Oct 27, 2017·Updated May 26, 2022

In Brief

A Phase 3 clinical trial evaluating Iontophoresis & tube placement and Tube placement for OME - Otitis Media With Effusion and AOM - Acute Otitis Media. Completed, enrolled 370 participants across 19 sites in 2 countries.

Detailed Summary

A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOME - Otitis Media With Effusion, AOM - Acute Otitis Media
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 27, 2017
Enrollment StartOct 31, 2017
Primary CompletionFeb 28, 2019
Study CompletionMar 25, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.7 years ago

Interventions

Iontophoresis & tube placementcombination

Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement.

Tube placementdevice

Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.