N/A N=323 Randomized Treatment

Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

Eustachian Tube Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT02087150 ↗

Enrolled (actual)

323

Serious AEs

2.2%

Results posted

Jan 2019

Primary outcome: Primary: Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks — 73; 10 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Acclarent Eustachian Tube Balloon Catheter (ETBC) (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Integra LifeSciences Corporation
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks	73; 10	—
SECONDARY Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks	128; 32	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02087150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.