Eustachian Tube Dysfunction Clinical Trial
Official title:
A Prospective, Multicenter Study to Evaluate Effectiveness and Safety of Lidocaine Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting
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).
The objective for Group B in the study is to evaluate tolerability and safety of tympanostomy
tube (TT) placement in adults following local anesthesia in a physician's clinic setting.
Group B will consist of 30 evaluable adults who require unilateral or bilateral tube
insertion.
The iontophoresis system (IPS) will be used to facilitate anesthetic delivery to the tympanic
membrane (TM). The lidocaine-based solution used for local anesthesia of the TM is Tymbion
(2% lidocaine HCl/ 1:100,000 epinephrine).
Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS
in all ears indicated for tube placement. The subject will rate the pain upon TDS tube
insertion using the VAS, and the pain score will be compared to a performance goal.
Safety will be evaluated post procedure and at a follow-up visit.
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