A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon
In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups. balloon dilation of the eustachian tube or nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months
• ≥18 years old (of both sexes)
• Diagnosed with persistent obstructive eustachian tube dysfunction (OETD) for at least 3 months prior to enrolment uni- and/or bilateral
• Diagnosis (both required):
• i. Persistent OETD symptoms assessed by Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with overall score of ≥3 (moderate to severe symptoms) for 3 months or more prior to enrollment.
• ii. Refractory to medical therapy (minimum of 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 3 months before study enrollment).