CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Tymbion Iontophoresis and Tube Delivery System (TDS)combination
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/NCT03197558
NCT03197558Phase 2Completed
CompareCT.gov

A Prospective, Multicenter Study to Evaluate Effectiveness and Safety of Lidocaine Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting

Tusker Medical·interventional·Posted Jun 23, 2017·Updated Jan 18, 2020

In Brief

A Phase 2 clinical trial evaluating Tymbion Iontophoresis and Tube Delivery System (TDS) for Barotrauma;Ear and 3 related conditions. Completed, enrolled 30 participants across 8 sites.

Detailed Summary

A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting. This study cohort is called Group B and includes tube placement. Protocol CPR007003 also included a first study group ('A', without tube placement) that was completed and described in a separate registration (NCT03119181).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBarotrauma;Ear, OME - Otitis Media With Effusion, AOM - Acute Otitis Media, Eustachian Tube Dysfunction
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 23, 2017
Enrollment StartJun 27, 2017
Primary CompletionSep 14, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.0 years ago

Interventions

Tymbion Iontophoresis and Tube Delivery System (TDS)combination

Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement.