Balloon Dilation for Eustachian Tube Dysfunction

Recruiting at 1 trial location

Overseen By Mohammad Aleinati, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Patulous ETD, TM perforation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 day

76 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that symptoms should persist despite using nasal steroid sprays or systemic steroids, suggesting you might continue these treatments if they are not effective.

What data supports the effectiveness of the treatment Balloon dilation of eustachian tube (Stryker XprESS LoProfile ENT dilation system)?

Research shows that balloon dilation of the Eustachian tube can be effective for treating Eustachian tube dysfunction, with studies indicating it is a safe and promising method for improving ear function in patients who do not respond to other treatments. ^{1 2 3 4 5}

Is balloon dilation of the Eustachian tube safe for humans?

Research shows that balloon dilation of the Eustachian tube is generally safe for humans, with studies evaluating its safety in both adults and children. These studies have looked at different methods and devices, and have not reported significant safety concerns. ^{5 6 7 8 9}

How is balloon dilation for Eustachian tube dysfunction different from other treatments?

Balloon dilation for Eustachian tube dysfunction is a minimally invasive procedure that uses a small balloon to open up the Eustachian tube, which is different from traditional treatments that may involve medication or more invasive surgery. This method is particularly useful for patients who do not respond to conventional therapies and offers a new option for a condition with limited treatment choices. ^{1 3 10 11 12}

Research Team

Justin Lui, MD, FRCSC

Principal Investigator

University of Calgary

Eligibility Criteria

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.

Inclusion Criteria

I have had ear pain, pressure, hearing issues, or tinnitus for over 3 months.

ETDQ7 ≥ 2.1 at enrollment

My ear symptoms improved within 3 days after treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomly assigned to undergo either balloon dilation of the eustachian tube or a placebo procedure

1 day

1 visit (in-person)

Follow-up

Participants repeat assessments and questionnaires over four follow-up appointments at 6, 24, and 52 weeks after the procedure

52 weeks

4 visits (in-person)

Optional Crossover

Participants in the placebo group are offered the option to cross-over into the BDET group at 6 weeks post-procedure

6 weeks

Treatment Details

Interventions

• Balloon dilation of eustachian tube (Stryker XprESS LoProfile ENT dilation system)
• Sham procedure

Trial Overview 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.

Participant Groups

Group I: Balloon dilation of eustachian tube Experimental Treatment 1 Intervention

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

Group II: Sham procedure Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Eustachian Tube Balloon Dilation: A Systematic Review and Meta-analysis of Treatment Outcomes. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Eustachian tube balloon dilation in treatment of equalization problems of freediving spearfishermen. [2020]

4. Denmark pubmed.ncbi.nlm.nih.gov

[Balloon dilation of Eustachian tube is a new treatment of chronic otitis media]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term Outcomes of Balloon Dilation for Persistent Eustachian Tube Dysfunction. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Balloon dilation of the Eustachian tube with a seeker-based device: A registry of 169 patients. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Fluoroscopy-guided balloon dilation in patients with Eustachian tube dysfunction. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Balloon Dilation for Obstructive Eustachian Tube Dysfunction in Children. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

In-office balloon dilation of the Eustachian tube under local anesthesia: A retrospective review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The Feasibility of Eustachian Tube Dilation With a Standard Endovascular Balloon: A Comparative Cadaver Study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Balloon dilation for eustachian tube dysfunction: systematic review. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Adverse Events and Subsequent Management Associated With Eustachian Tube Balloon Dilation. [2023]