XprESS Eustachian Tube Dilation Study

Study Overview
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Brief Summary
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Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.

Detailed Description
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Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.

Official Title
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XprESS Eustachian Tube Dilation Study

Conditions
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Eustachian Tube Dysfunction

Intervention / Treatment
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* Device: XprESS
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old Have been diagnosed with symptoms of chronic Eustachian tube dysfunction for no less than 12 months prior to enrollment Have an overall ETDQ-7 score ≥3.0 Have record of failed medical management for Eustachian tube dysfunction Exclusion Criteria: Require concomitant procedures at the time of the study enrollment or procedure Have patulous Eustachian tube Have ear tubes in place or perforation of the tympanic membrane Have evidence of internal carotid artery dehiscence Be pregnant at the time of enrollment Be currently participating in other drug or device studies

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XprESS<br>Balloon dilation of the Eustachian tube | Device: XprESS<br>* Balloon dilation of the Eustachian tube<br>|
| Other: Control<br>Continued medical management | Other: Control<br>* Continued medical management<br>* Other names: Continued medical management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Overall ETDQ-7 Scores | Comparison of mean change in overall ETDQ-7 scores from baseline to 6 weeks between randomized arms. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms. | 6 weeks post procedure (treatment arm) or randomization (control arm) | 
| Complication Rate | Number of subjects who experience serious device- or procedure-related adverse events | Through 6 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success Rate | Percent of successful ET dilations per attempted ET dilations | Immediately after procedure | 
| Revision Rate | Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device | 12 months | 
| Mean Change in Overall ETDQ-7 Score | Mean change from baseline to 12 months in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms. | 12 months postdilation | 
| Mean Change in Overall ETDQ-7 Score | Mean change from baseline to 6 months in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms. | 6 months postdilation | 
| Mean Change in Overall ETDQ-7 Score | Mean change from baseline to 3 months in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms. | 3 months postdilation | 
| Mean Change in Overall ETDQ-7 Score | Mean change from baseline to 6 weeks in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms. | 6 weeks postdilation |