Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)

Integra LifeSciences

Status

Completed

Conditions

Eustachian Tube Dysfunction

Treatments

Device: Acclarent Eustachian Tube Balloon Catheter (ETBC)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02087150

CPR005029

Details and patient eligibility

About

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.

Enrollment

323 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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