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Procedure

Eustachian tube dilation for Bilateral Eustachian Tube Dysfunction

N/A
Waitlist Available
Led By Trung Le, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Eustachian Tube Dysfunction
  • Bilateral Eustachian Tube Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Succesfull procedure
Secondary study objectives
CT
ETDQ - 7 (Eustachian Tube Dysfunction Questionnaire - Item 7)
Endoscopic evaluation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Eustachian tube dilationExperimental Treatment1 Intervention
Eustachian tube dilation with an endovascular balloon
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eustachian tube dilation
2021
N/A
~20

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
677 Previous Clinical Trials
1,565,627 Total Patients Enrolled
Trung Le, MDPrincipal InvestigatorSunnybrook Health Sciences Center
~3 spots leftby Dec 2025