Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)

Conditions
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Eustachian Tube Dysfunction

Intervention / Treatment
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* Device: Acclarent Eustachian Tube Balloon Catheter (ETBC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Medical management (MM)<br>Medical management will consist of 6 weeks of daily intranasal steroid (triamcinolone acetonide) | |
| Experimental: Eustachian tube balloon catheter (ETBC) plus MM<br>Eustachian tube dilation with the ETBC plus medical management | Device: Acclarent Eustachian Tube Balloon Catheter (ETBC)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks | 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 | 6 Week Follow-Up Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks | The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD. | 6 Week Follow-Up Visit |