Balloon Dilation of the Eustachian Tube (BDET)

September 6, 2023 updated by: Sunnybrook Health Sciences Centre

A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon

In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups.

  1. balloon dilation of the eustachian tube or
  2. nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients will eustachian tube dysfunction will be asked to participate in the study.

They will be randomized to one of two groups

group 1 - surgical dilation of the eustachian tube in general anaesthesia

group 2 - daily nasal saline spray, twice a day

Regular Follow up with Tympanogram and Questionnaire

After three months patient in the control group (nasal saline) can switch in the intervention group.

Eustachian tube dilation will be carried out with a Health Canada and FDA approved device, usually used for endovascular balloon dilation. It has the same size and pressure properties as the eustachian tube dilation device and has shown a good safety profile in a previous preclinical and clinical pilot study.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years old (of both sexes)
  • Diagnosed with persistent obstructive eustachian tube dysfunction (OETD) for at least 3 months prior to enrolment uni- and/or bilateral

Diagnosis (both required):

i. Persistent OETD symptoms assessed by Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with overall score of ≥3 (moderate to severe symptoms) for 3 months or more prior to enrollment.

ii. Refractory to medical therapy (minimum of 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 3 months before study enrollment).

Exclusion Criteria:

  • Patulous eustachian tube
  • Prior eustachian tube intervention
  • Presence of myringotomy ventilation tube or a tympanic membrane perforation
  • Active chronic or acute otitis media
  • Chronic otitis media with cholesteatoma
  • Fluctuating sensorineural hearing loss or Meniere's disease
  • Chronic rhinosinusitis, allergies, or reflux disease not controlled with medication
  • History of head or neck surgery within 3 months
  • Prior radiation to the head and neck
  • Active temporomandibular joint disorders
  • Cleft palate or Craniofacial syndrome
  • Cystic fibrosis or Ciliary dysmotility syndrome or Systemic immunodeficiencies
  • Active acute upper respiratory infection
  • Nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the Eustachian tube
  • CT temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression
  • Patient unable to follow protocol for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eustachian tube dilation
Surgical Eustachian tube dilation in general anaesthesia
Device: Balloon dilation of the eustachian tube
Balloon dilation of the eustachian tube
No Intervention: Control Group
nasal saline spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Otoscopy, Normal, Retracted or Middle ear effusion
Time Frame: 6 weeks
Microscopic evaluation of tympanic membrane
6 weeks
Otoscopy, Normal, Retracted or Middle ear effusion
Time Frame: 3 motnths
Microscopic evaluation of tympanic membrane
3 motnths
Otoscopy, Normal, Retracted or Middle ear effusion
Time Frame: 6 months
Microscopic evaluation of tympanic membrane
6 months
Otoscopy, Normal, Retracted or Middle ear effusion
Time Frame: 12 months
Microscopic evaluation of tympanic membrane
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Valsalva maneuver -positive or negative
Time Frame: 6 weeks
Subjective effectiveness of Valsalva maneuver
6 weeks
Valsalva maneuver -positive or negative
Time Frame: 3 months
Subjective effectiveness of Valsalva maneuver
3 months
Valsalva maneuver -positive or negative
Time Frame: 6 months
Subjective effectiveness of Valsalva maneuver
6 months
Valsalva maneuver -positive or negative
Time Frame: 12 months
Subjective effectiveness of Valsalva maneuver
12 months
Tympanogram
Time Frame: 3 months
Measurement with tympanometer
3 months
Tympanogram
Time Frame: 6 months
Measurement with tympanometer
6 months
Tympanogram
Time Frame: 12 months
Measurement with tympanometer
12 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Time Frame: 6 weeks
Questionnaire
6 weeks
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Time Frame: 3 months
Questionnaire
3 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Time Frame: 6 months
Questionnaire
6 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Time Frame: 12 months
Questionnaire
12 months
HUI (Health utility index)
Time Frame: 6 weeks
Questionnaire
6 weeks
HUI (Health utility index)
Time Frame: 3 months
Questionnaire
3 months
HUI (Health utility index)
Time Frame: 6 months
Questionnaire
6 months
HUI (Health utility index)
Time Frame: 12 months
Questionnaire
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Trung N Le, MD, PhD, Sunnybrook Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2022

Primary Completion (Actual)

May 28, 2023

Study Completion (Actual)

August 28, 2023

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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