Eustachian Tube DysfunctionBDETNCT05270031
Balloon Dilation of the Eustachian Tube
A study testing Balloon dilation of the eustachian tube in people with Eustachian Tube Dysfunction, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eustachian Tube Dysfunction
- What is being tested?
- Balloon dilation of the eustachian tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 24 Feb 2022to 28 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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):
- 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.
- 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).
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- balloon dilation of the eustachian tube or
- nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months
Read the 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.
- Conditions
- Eustachian Tube Dysfunction
- Being tested
- Balloon dilation of the eustachian tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon dilation of the eustachian tubeDevice
Balloon dilation of the eustachian tube
| Study group | Role | What they receive |
|---|---|---|
| Eustachian tube dilation | Experimental | Surgical Eustachian tube dilation in general anaesthesia Receives: Device: Balloon dilation of the eustachian tube |
| Control Group | No intervention | nasal saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Otoscopy, Normal, Retracted or Middle ear effusion
Microscopic evaluation of tympanic membrane
Measured: 6 weeks
Otoscopy, Normal, Retracted or Middle ear effusion
Microscopic evaluation of tympanic membrane
Measured: 3 motnths
Otoscopy, Normal, Retracted or Middle ear effusion
Microscopic evaluation of tympanic membrane
Measured: 6 months
Otoscopy, Normal, Retracted or Middle ear effusion
Microscopic evaluation of tympanic membrane
Measured: 12 months
Secondary outcomes (15)
Valsalva maneuver -positive or negative
Subjective effectiveness of Valsalva maneuver
Measured: 6 weeks
Valsalva maneuver -positive or negative
Subjective effectiveness of Valsalva maneuver
Measured: 3 months
Valsalva maneuver -positive or negative
Subjective effectiveness of Valsalva maneuver
Measured: 6 months
Valsalva maneuver -positive or negative
Subjective effectiveness of Valsalva maneuver
Measured: 12 months
Tympanogram
Measurement with tympanometer
Measured: 3 months
Tympanogram
Measurement with tympanometer
Measured: 6 months
Tympanogram
Measurement with tympanometer
Measured: 12 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Questionnaire
Measured: 6 weeks
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Questionnaire
Measured: 3 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Questionnaire
Measured: 6 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Questionnaire
Measured: 12 months
HUI (Health utility index)
Questionnaire
Measured: 6 weeks
HUI (Health utility index)
Questionnaire
Measured: 3 months
HUI (Health utility index)
Questionnaire
Measured: 6 months
HUI (Health utility index)
Questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start24 Feb 2022
- Primary completion28 May 2023
- Study completion28 Aug 2023
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross Over after 3 months possible
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trung N Le, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270031
- Sponsor's protocol ID
- 3156
- Acronym
- BDET
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.
PubMed 40008607
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon
- ClinicalTrials.gov ID
- NCT05270031
- Acronym / sponsor ID
- BDET / 3156
- Conditions
- Eustachian Tube Dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups.
- balloon dilation of the eustachian tube or
- nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross Over after 3 months possible
| Arm | Type | Receives |
|---|---|---|
| Eustachian tube dilation | Experimental | Device: Balloon dilation of the eustachian tubeSurgical Eustachian tube dilation in general anaesthesia |
| Control Group | No intervention | –nasal saline spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
- 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.
- 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).
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon dilation of the eustachian tubeBalloon dilation of the eustachian tube | Device | Eustachian tube dilation |
Primary outcome
Otoscopy, Normal, Retracted or Middle ear effusion
Time frame: 6 weeks
Microscopic evaluation of tympanic membrane
Otoscopy, Normal, Retracted or Middle ear effusion
Time frame: 3 motnths
Microscopic evaluation of tympanic membrane
Otoscopy, Normal, Retracted or Middle ear effusion
Time frame: 6 months
Microscopic evaluation of tympanic membrane
Otoscopy, Normal, Retracted or Middle ear effusion
Time frame: 12 months
Microscopic evaluation of tympanic membrane
15 secondary outcomes
Valsalva maneuver -positive or negative
Time frame: 6 weeks
Valsalva maneuver -positive or negative
Time frame: 3 months
Valsalva maneuver -positive or negative
Time frame: 6 months
Valsalva maneuver -positive or negative
Time frame: 12 months
Tympanogram
Time frame: 3 months
Tympanogram
Time frame: 6 months
Tympanogram
Time frame: 12 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Time frame: 6 weeks
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Time frame: 3 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Time frame: 6 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Time frame: 12 months
HUI (Health utility index)
Time frame: 6 weeks
HUI (Health utility index)
Time frame: 3 months
HUI (Health utility index)
Time frame: 6 months
HUI (Health utility index)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Derived from this study: PubMed 40008607Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trung N Le, MD, PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon dilation of the eustachian tube in people with Eustachian Tube Dysfunction, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Otoscopy, Normal, Retracted or Middle ear effusion (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.