This trial is active, not recruiting.

Condition eustachian tube dysfunction (etd)
Treatment acclarent eustachian tube balloon catheter (etbc)
Sponsor Acclarent
Start date February 2014
End date April 2016
Trial size 323 participants
Trial identifier NCT02087150, CPR005029


The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(No Intervention)
Medical management will consist of 6 weeks of daily intranasal steroid (triamcinolone acetonide)
Eustachian tube dilation with medical management for Eustachian tube dysfunction. Eustachian tube dilation will be conducted using the Acclarent Eustachian Tube Balloon Catheter (ETBC). Medical management will consist of intranasal steroid.
acclarent eustachian tube balloon catheter (etbc)

Primary Outcomes

Proportion of subjects experiencing normalization of tympanometry
time frame: 6 weeks

Secondary Outcomes

ETDQ-7 score (Eustachian tube dysfunction questionnaire)
time frame: 6 weeks

Eligibility Criteria

Male or female participants at least 22 years old.

Inclusion Criteria: - Adult male or female aged 22 years and older - Persistent Eustachian tube dysfunction - Failure of medical management - Positive diagnosis of ETD - Absence of internal carotid artery (ICA) dehiscence - Able to read and understand English Exclusion Criteria: - Females who are pregnant or lactating - Anatomy that requires an adjunctive surgical procedure - Concomitant nasal or sinus procedures planned on the same day as surgical procedure - Concomitant ear procedures planned on the same day as surgical procedure - History of major surgery of the head or neck within four (4) months prior to surgery - History of patulous ET - History of fluctuating sensorineural hearing loss - Active acute otitis media - Tympanic membrane perforation - Tympanosclerosis - Acute upper respiratory infection - Temporomandibular joint disorder - Cleft palate - Craniofacial syndrome - Cystic fibrosis - Ciliary dysmotility syndrome - Systemic mucosal or immunodeficiency disease - Intolerance of medication for ETD - Prior intervention of Eustachian tube

Additional Information

Official title A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)
Principal investigator Dennis Poe, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Acclarent.