Clinically proven with patients with persistent Eustachian tube dysfunction (ETD)
Patient inclusion criteria used to determine if a patient was a potential candidate with persistent ETD for admission into "A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)”.
Clinical evidence study methodology
The study was a prospective, multicenter, randomized, controlled trial to demonstrate superiority of the Eustachian tube balloon dilation with Eustachian tube balloon catheter in conjunction with medical management compared to medical management alone.
Diagnosis and main criteria for inclusion
- Subjects age 22 and older diagnosed with persistent ETD.
- Persistent ETD is defined by patient-reported symptoms of ETD for 12 weeks or greater.
- Failure of medical management consisting of either a minimum of 4
weeks of continuous daily usage of any intranasal steroid spray or a
minimum of one completed course of an oral steroid.
- Patients were required to have a computed tomography (CT) scan to confirm absence of internal carotid artery (ICA) dehiscence in the ET lumen.
- An abnormal tympanometry (type B or C) after failed medical
- Demonstrated symptomatic dysfunction as documented through a
validated quality of life instrument (ETDQ-7) with a score ≥ 2.1 after
failed medical management.
Downloadthe Eustachian Tube Dysfunction Questionnaire