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Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)

NCT03197558 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-01-18

Study results available
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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).

Conditions

  • Barotrauma;Ear
  • OME - Otitis Media With Effusion
  • AOM - Acute Otitis Media
  • Eustachian Tube Dysfunction

Interventions

COMBINATION_PRODUCT

Tymbion Iontophoresis and Tube Delivery System (TDS)

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

Sponsors & Collaborators

  • Tusker Medical

    lead INDUSTRY

Principal Investigators

  • David Yen, MD · Specialty Physician Associates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2017-09-14
Completion
2017-09-14
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 NCT03197558 on ClinicalTrials.gov