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Study to Compare Active Tymbion Iontophoresis to Sham Tymbion Iontophoresis for Anesthesia of the Tympanic Membrane

NCT03119181 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-18

Study results available
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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).

Conditions

  • Healthy Volunteer

Interventions

DRUG

Tymbion Lidocaine/epinephrine solution

The external ear canal will be filled with Tymbion drug solution

COMBINATION_PRODUCT

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

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

Sponsors & Collaborators

  • Tusker Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-27
Primary Completion
2017-05-11
Completion
2017-05-11
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03119181 on ClinicalTrials.gov