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Device

Balloon dilation of the eustachian tube for Eustachian Tube Dysfunction (BDET Trial)

N/A
Waitlist Available
Led By Trung N Le, MD, PhD
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
Diagnosed with persistent obstructive eustachian tube dysfunction (OETD) for at least 3 months prior to enrolment uni- and/or bilateral
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

BDET Trial Summary

This trial is testing two treatments for eustachian tube dysfunction: balloon dilation and nasal saline. Patients will be followed for a year, and can switch treatments after 3 months if they want.

Eligible Conditions
  • Eustachian Tube Dysfunction

BDET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with ongoing ear tube blockage for at least 3 months before joining the study, either in one or both ears.

BDET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Otoscopy, Normal, Retracted or Middle ear effusion
Secondary outcome measures
ETDQ-7 (eustachian tube dilation questionnaire - seven)
HUI (Health utility index)
Tympanogram
+1 more

BDET Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Eustachian tube dilationExperimental Treatment1 Intervention
Surgical Eustachian tube dilation in general anaesthesia
Group II: Control GroupActive Control1 Intervention
nasal saline spray

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
651 Previous Clinical Trials
1,542,674 Total Patients Enrolled
Trung N Le, MD, PhDPrincipal InvestigatorSunnybrook Health Sciences Center

Media Library

Balloon dilation of the eustachian tube (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05270031 — N/A
Eustachian Tube Dysfunction Research Study Groups: Eustachian tube dilation, Control Group
Balloon dilation of the eustachian tube (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05270031 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this study ongoing?

"Per clinicaltrials.gov, the participants for this medical trial are being actively recruited right now. The first post was made on February 24th 2022 and last modified a day later."

Answered by AI

What is the aggregate of individuals participating in this clinical experiment?

"Yes, the details available on clinicaltrials.gov support that this investigation is presently inviting applications from participants. This medical research was initially posted on February 24th 2022 and last modified on February 25th 2022. Approximately 58 individuals are required for this trial at a single location."

Answered by AI

Who else is applying?

What site did they apply to?
Sunnybrook Health Sciences Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have had this issue for at least 5 years and have just heard about this treatment.
PatientReceived 1 prior treatment
~5 spots leftby Mar 2025