A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 323
- Locations
- 21
- Primary Endpoint
- Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Medical management (MM)
Medical management will consist of 6 weeks of daily intranasal steroid (triamcinolone acetonide)
Eustachian tube balloon catheter (ETBC) plus MM
Eustachian tube dilation with the ETBC plus medical management
Intervention: Acclarent Eustachian Tube Balloon Catheter (ETBC) (Device)
Outcomes
Primary Outcomes
Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks
Time Frame: 6 Week Follow-Up Visit
The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function
Secondary Outcomes
- Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks(6 Week Follow-Up Visit)