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

NCT03197558 PHASE2 COMPLETED Results posted

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).

Details

Lead sponsor	Tusker Medical
Phase	PHASE2
Status	COMPLETED
Enrolment	30
Start date	Tue Jun 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Sep 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

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

Interventions

• Tymbion Iontophoresis and Tube Delivery System (TDS)

Countries

United States