What side effects are associated with this type of intervention?

Balloon dilation of the Eustachian tube, a procedure that mechanically widens the tube to improve function, is generally considered safe but can have some side effects. These may include temporary discomfort or pain, bleeding, and, in rare cases, infection or injury to the Eustachian tube or surrounding structures. Other common treatments, such as nasal steroid sprays and decongestants, may cause side effects like nasal irritation, dryness, and, less commonly, systemic effects such as increased blood pressure or heart rate.

What prior FDA approvals exist?

The FDA has approved various treatments for Eustachian Tube Dysfunction, primarily focusing on medical management with nasal steroid sprays and decongestants. However, these medical options have shown limited effectiveness. The balloon dilation of the eustachian tube is a newer procedure being studied, which mechanically widens the eustachian tube to improve its function and alleviate dysfunction. This method is being evaluated for its safety and efficacy compared to traditional treatments.

What other types of research exist?

Promising novel alternatives to Balloon Dilation of the Eustachian Tube for ETD patients include: 1) Eustachian tube stenting, which involves placing a stent to keep the tube open and improve ventilation; 2) Radiofrequency ablation, which uses targeted energy to reduce tissue bulk and improve tube function; and 3) Advanced pharmacological treatments, such as targeted anti-inflammatory or mucolytic agents, which aim to reduce inflammation and improve eustachian tube patency.

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Procedure

Balloon Dilation for Eustachian Tube Dysfunction

N/A

Recruiting

Led By Justin Lui, MD, FRCSC

Research Sponsored by University of Calgary

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 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention

Summary

This trial is testing a procedure called balloon dilation of the eustachian tube for adults with ear pressure problems that haven't improved with other treatments. The procedure uses a small balloon to widen the eustachian tube, helping it work better and reduce symptoms. Balloon dilation of the eustachian tube (BDET) is a commonly performed procedure.

Who is the study for?

This trial is for individuals with persistent eustachian tube dysfunction who haven't improved after using nasal sprays or decongestants, or those experiencing barotitis media symptoms regularly. Participants must have documented ear drum movement issues and a history of related symptoms like ear pain, pressure, hearing changes, tinnitus, or vertigo.

What is being tested?

The study tests if balloon dilation of the eustachian tube is more effective than a sham (placebo) procedure in treating eustachian tube dysfunction. Patients will be randomly assigned to one of the procedures and followed up with various assessments over a year.

What are the potential side effects?

While re-confirming safety is part of this study's goals, potential side effects may include discomfort during the procedure, temporary hearing changes or dizziness post-procedure, and possible risk of infection similar to other ear interventions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ7) score

Change in symptoms (ad hoc baro-challenge ETDD symptom questionnaire)

Secondary study objectives

Ad hoc work/activity impairment questionnaire score

Change in audiogram (pure tone average thresholds)

Change in tympanogram type and pressure at peak compliance

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Balloon dilation of eustachian tubeExperimental Treatment1 Intervention

These patient will undergo balloon dilation dilation of the eustachian tube.

Group II: Sham procedurePlacebo Group1 Intervention

These patients will undergo a sham procedure, where the motions of balloon dilation of the eustachian tube will be simulated.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Eustachian Tube Dysfunction (ETD) include nasal steroid sprays, decongestants, and ear tube placement. Nasal steroid sprays and decongestants aim to reduce mucosal edema and inflammation, thereby improving the patency of the eustachian tube. Ear tube placement helps to ventilate the middle ear and equalize pressure. Balloon dilation of the eustachian tube, a newer treatment, mechanically widens the eustachian tube to improve its function and alleviate dysfunction. This is particularly important for ETD patients as it directly addresses the structural issues causing the dysfunction, potentially providing more effective and lasting relief compared to other treatments.