Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction

Summary

This study is being conducted to learn more about a procedure, balloon dilation of the eustachian tube, in treating patients with eustachian tube dysfunction. Traditionally, eustachian tube dysfunction is treated with nasal steroid sprays and decongestants, or by placement of ear tubes. However, current evidence suggest that medical options are ineffective, and placement of ear tubes is not risk-free. The investigators are carrying out this research study with the following goals:

1. Determine if balloon dilation of the eustachian tube is superior to a placebo procedure in treating patients with eustachian tube dilatory dysfunction
2. Identify patient variables associated with positive response to balloon dilation of the eustachian tube
3. Re-demonstrate the safety of balloon dilation of the eustachian tube

What does participation in this study involve? Participants in this study will:

* Agree to be randomly assigned to undergo either: balloon dilation of the eustachian tube, or a placebo procedure, with the option to undergo dilation of the eustachian tube 6 weeks later
* Agree to allowing the investigators access to their personal health information
* Complete the following assessments and questionnaires in clinic before undergoing balloon dilation or placebo procedure:

* A questionnaire to assess your eustachian tube dysfunction
* An assessment of the movement of your ear drum (tympanogram)
* A hearing test (audiogram)
* A questionnaire to assess the impact of eustachian tube dysfunction on work/activity
* A questionnaire to assess overall health-related quality of life
* An assessment of the ability to equalize middle ear pressure(s)
* Visual examination of the ear drums
* Repeat the above assessments and questionnaires over the course of four follow-up appointments at 6-, 24-, and 52-weeks after the procedure.

Conditions

• Eustachian Tube Dysfunction
• Barotitis

Interventions

DEVICE

Balloon dilation of eustachian tube

Patients in the intervention group would undergo balloon dilation of the eustachian tube under local anesthetic in clinic. The Stryker XprESS LoProfile ENT dilation system or the Stryker Audion ET dilation system will be used.

OTHER

Sham procedure

Patients in the sham group will undergo the motions of an in-office dilation of the eustachian tube, without actually dilating the eustachian tube.

Sponsors & Collaborators

• University of Calgary

  lead OTHER

Principal Investigators

• Justin Lui, MD, FRCSC · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-25

Primary Completion

2025-12-01

Completion

2025-12-01

FDA Device

Yes

Countries

• Canada

Study Locations