Eustachian Tube Dilation With an Endovascular Balloon

Study Overview
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Brief Summary
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The Eustachian tube is a narrow tube which links the back of the nose to the middle ear. Eustachian tube dysfunction may occur when the mucosal lining of the tube is swollen, or does not open or close properly. It can occur after the start of a cold and other nose, sinus, ear and throat infections causing ear pain and pressure, fullness, cracking/popping sounds. This is an ubiquitous healthcare problem, affecting children and adults, that can lead to severe consequences including hearing loss, chronic otitis media, tinnitus, and vertigo. Numerous studies have consistently failed to support the effectiveness of medical managements. Pressure equalizing tubes are considered a temporary solution that does not treat the underlying pathology. More recent preliminary evidence of using inflation of a noncompressible balloon in the eustachian tube improved clinical outcomes, patients' symptoms and quality of life. This eustachian dilation catheter is not accessible in Canada since the device and procedure is not covered by OHIP (Ontario health insurance plan) or any other health insurance in Canada. In a cadaver study, we have evaluated using an endovascular balloon (Balloon that is used to dilate (expand) vessels) for eustachian tube dilation, which only costs about 10% of the eustachian tube dilation device. This endovascular balloon is Health Canada approved, but not for this specific use. We therefore want to conduct a pilot safety study with the main goal of assessing feasibility of eustachian tube dilation with the endovascular device.

Official Title
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Eustachian Tube Dilation Using an Angioplasty Balloon - a Pilot Safety Study

Conditions
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Eustachian Tube Dysfunction, Eustachian Tube Dysfunction of Both Ears

Intervention / Treatment
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* Device: Eustachian tube dilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old (of both sexes) Diagnosed with unilateral or bilateral persistent obstructive eustachian tube dysfunction (OETD) Undergoing tympanoplasty or tympanomastoidectomy Exclusion Criteria: Patulous eustachian tube Preoperative nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the Eustachian tube CT temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression Patient unable to follow protocol for any reason Cleft palate or Craniofacial syndrome Prior eustachian tube intervention Prior radiation to the head and neck

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eustachian tube dilation<br>Eustachian tube dilation with an endovascular balloon | Device: Eustachian tube dilation<br>* Dilation of the eustachian tube with an endovascular balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Succesfull procedure | o Feasibility to perform the procedure after ear surgery with no local complication and within 15-20 minutes | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT | o Safety evaluated after the procedure CT scan. Complications (adverse and serious adverse events related to the device or procedure) | 5 minutes | 
| ETDQ - 7 (Eustachian Tube Dysfunction Questionnaire - Item 7) | o Mean change in overall ETDQ-7 scores from baseline at 2- and 6-months follow-up | 2 minutes | 
| Endoscopic evaluation | Safety evaluated after the procedure by endoscopic examination and CT scan. Complications (adverse and serious adverse events related to the device or procedure) | 5 minutes |