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

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).

Timeline

Start

2017-06-27

Primary completion

2017-09-14

Completion

2017-09-14

Drugs

Indications