CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Tymbion Lidocaine/epinephrine solution +1 moredrug
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/NCT03119181
NCT03119181Phase 2Completed
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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

Tusker Medical·interventional·Posted Apr 18, 2017·Updated Jan 18, 2020

In Brief

A Phase 2 clinical trial evaluating Tymbion Lidocaine/epinephrine solution and Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution for Healthy Volunteer. Completed, enrolled 40 participants across 2 sites.

Detailed Summary

A prospective, multicenter study to determine if active Tymbion iontophoresis is superior to sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane (TM). The study will use the Tula iontophoresis systems for healthy adult volunteers in an office setting, called Group A of Protocol CPR007003. The protocol CPR007003 also includes a Group B study described in a separate Registration (NCT03197558).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 18, 2017
Enrollment StartApr 27, 2017
Primary CompletionMay 11, 2017
TodayJul 2, 2026
Enrollment to primary: 14 daysPosted 9.2 years ago

Interventions

Tymbion Lidocaine/epinephrine solutiondrug

The external ear canal will be filled with Tymbion drug solution

Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solutioncombination

The external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM