Balloon Dilatation for Eustachian Tube Obstruction: A Randomised Control Trial

Not Applicable

• Conditions: Eustachian tube dysfunction; Ear - Other ear disorders; Ear - Normal ear development and function

• Registration Number: ACTRN12618001681246
• Lead Sponsor: Kolling Deafness Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-11
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

To be eligible to enroll in the study patients must:
•Provide informed consent to participate in the study
•Have a diagnosis of persistent ETDD (A positive diagnosis is confirmed by the presence of abnormal tympanometry and symptomatic dysfunction as documented by the ETDQ-7 questionnaire mean item score greater than 2.1, for 12 weeks or more prior to enrollment in the study)
•Be 22 years of age or older with persistent ETDD and have failed medical management consisting of either 4 weeks of continuous daily usage of intranasal corticosteroids spray or a minimum of 1 completed course of oral steroids within 90-days prior to study enrollment.
•Have a recent (or be able to undergo a) CT petrous temporal bone
•Be able to undergo fibreoptic nasendoscopy

Exclusion Criteria

Exclusion criteria include the following:
•Anatomy that requires an adjunctive surgical procedure
•Planned concomitant nasal, sinus or ear procedures during the study
•History of major head and neck surgery within 4 months or randomization
•History of head and neck radiation
•Diagnosis of patulous eustachian tube
•Fluctuating sensorineural hearing loss
•Active acute or chronic otitis media
•Tympanic membrane perforation or the presence of a tympanostomy tube (grommet)
•Presence of tympanosclerosis
•Acute upper respiratory tract infection
•Active temporomandibular joint disorder
•Cleft palate or a history of cleft palate repair
•History of craniofacial syndrome
•History of cystic fibrosis
•History of ciliary dysmotility syndrome
•History of systemic mucosal diseases or immunodeficiency disorders
•Intolerance of protocol-defined medication regimen
•Prior surgical ET intervention
•Limited dilatory muscular contractions on endoscopy of the ET
•Contraindications to BDET

Study & Design

• Study Type: Interventional
• Study Design: Not specified