Eustachian Tube DysfunctionNCT04809753
Eustachian Tube Dilation With an Endovascular Balloon
A study testing Eustachian tube dilation in people with Eustachian Tube Dysfunction and Eustachian Tube Dysfunction of Both Ears, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The Eustachian tube is a narrow tube which links the back of the nose to the middle ear. Eustachian tube dysfunction may occur when the mucosal lining of the tube is swollen, or does not open or close properly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eustachian Tube Dysfunction, Eustachian Tube Dysfunction of Both Ears
- What is being tested?
- Eustachian tube dilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 29 Mar 2021to 28 Feb 2022
- 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 unilateral or bilateral persistent obstructive eustachian tube dysfunction (OETD)
- Undergoing tympanoplasty or tympanomastoidectomy
Who cannot join
- Patulous eustachian tube
- Preoperative 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
- Cleft palate or Craniofacial syndrome
- Prior eustachian tube intervention
- Prior radiation to the head and neck
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eustachian Tube Dilation Using an Angioplasty Balloon - a Pilot Safety Study
The Eustachian tube is a narrow tube which links the back of the nose to the middle ear. Eustachian tube dysfunction may occur when the mucosal lining of the tube is swollen, or does not open or close properly. It can occur after the start of a cold and other nose, sinus, ear and throat infections causing ear pain and pressure, fullness, cracking/popping sounds. This is an ubiquitous healthcare problem, affecting children and adults, that can lead to severe consequences including hearing loss, chronic otitis media, tinnitus, and vertigo. Numerous studies have consistently failed to support the effectiveness of medical managements. Pressure equalizing tubes are considered a temporary solution that does not treat the underlying pathology. More recent preliminary evidence of using inflation of a noncompressible balloon in the eustachian tube improved clinical outcomes, patients' symptoms and quality of life. This eustachian dilation catheter is not accessible in Canada since the device and procedure is not covered by OHIP (Ontario health insurance plan) or any other health insurance in Canada. In a cadaver study, we have evaluated using an endovascular balloon (Balloon that is used to dilate (expand) vessels) for eustachian tube dilation, which only costs about 10% of the eustachian tube dilation device. This endovascular balloon is Health Canada approved, but not for this specific use. We therefore want to conduct a pilot safety study with the main goal of assessing feasibility of eustachian tube dilation with the endovascular device.
- Being tested
- Eustachian tube dilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eustachian tube dilationDevice
Dilation of the eustachian tube with an endovascular balloon
| Study group | Role | What they receive |
|---|---|---|
| Eustachian tube dilation | Experimental | Eustachian tube dilation with an endovascular balloon Receives: Device: Eustachian tube dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Succesfull procedure
- Feasibility to perform the procedure after ear surgery with no local complication and within 15-20 minutes
Measured: 20 minutes
Secondary outcomes (3)
CT
- Safety evaluated after the procedure CT scan. Complications (adverse and serious adverse events related to the device or procedure)
Measured: 5 minutes
ETDQ - 7 (Eustachian Tube Dysfunction Questionnaire - Item 7)
- Mean change in overall ETDQ-7 scores from baseline at 2- and 6-months follow-up
Measured: 2 minutes
Endoscopic evaluation
Safety evaluated after the procedure by endoscopic examination and CT scan. Complications (adverse and serious adverse events related to the device or procedure)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start29 Mar 2021
- Primary completion20 Aug 2021
- Study completion28 Feb 2022
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trung Le, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809753
- Sponsor's protocol ID
- 3776
- Status last verified
- Oct 2022
- First submitted
- 24 Feb 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (consent form (anonymized), study protocol) will be shared upon reasonable request after publication
Publications
Dahm V, Lui JT, Jung S, Lin VY, Chen JM, Le TN. The feasibility and safety of eustachian tube dilation with a standard endovascular balloon: a clinical pilot study. J Otolaryngol Head Neck Surg. 2023 Feb 28;52(1):20. doi: 10.1186/s40463-022-00599-1.
PubMed 36855202
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eustachian Tube Dilation Using an Angioplasty Balloon - a Pilot Safety Study
- ClinicalTrials.gov ID
- NCT04809753
- Acronym / sponsor ID
- 3776
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 22 Mar 2021 (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.
The Eustachian tube is a narrow tube which links the back of the nose to the middle ear. Eustachian tube dysfunction may occur when the mucosal lining of the tube is swollen, or does not open or close properly. It can occur after the start of a cold and other nose, sinus, ear and throat infections causing ear pain and pressure, fullness, cracking/popping sounds. This is an ubiquitous healthcare problem, affecting children and adults, that can lead to severe consequences including hearing loss, chronic otitis media, tinnitus, and vertigo. Numerous studies have consistently failed to support the effectiveness of medical managements. Pressure equalizing tubes are considered a temporary solution that does not treat the underlying pathology. More recent preliminary evidence of using inflation of a noncompressible balloon in the eustachian tube improved clinical outcomes, patients' symptoms and quality of life. This eustachian dilation catheter is not accessible in Canada since the device and procedure is not covered by OHIP (Ontario health insurance plan) or any other health insurance in Canada. In a cadaver study, we have evaluated using an endovascular balloon (Balloon that is used to dilate (expand) vessels) for eustachian tube dilation, which only costs about 10% of the eustachian tube dilation device. This endovascular balloon is Health Canada approved, but not for this specific use. We therefore want to conduct a pilot safety study with the main goal of assessing feasibility of eustachian tube dilation with the endovascular device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eustachian tube dilation | Experimental | Device: Eustachian tube dilationEustachian tube dilation with an endovascular balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old (of both sexes)
- Diagnosed with unilateral or bilateral persistent obstructive eustachian tube dysfunction (OETD)
- Undergoing tympanoplasty or tympanomastoidectomy
Key exclusion criteria (7 listed)
- Patulous eustachian tube
- Preoperative 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
- Cleft palate or Craniofacial syndrome
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 |
|---|---|---|
| Eustachian tube dilationDilation of the eustachian tube with an endovascular balloon | Device | Eustachian tube dilation |
Primary outcome
Succesfull procedure
Time frame: 20 minutes
o Feasibility to perform the procedure after ear surgery with no local complication and within 15-20 minutes
3 secondary outcomes
CT
Time frame: 5 minutes
ETDQ - 7 (Eustachian Tube Dysfunction Questionnaire - Item 7)
Time frame: 2 minutes
Endoscopic evaluation
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 36855202Dahm V, Lui JT, Jung S, Lin VY, Chen JM, Le TN. The feasibility and safety of eustachian tube dilation with a standard endovascular balloon: a clinical pilot study. J Otolaryngol Head Neck Surg. 2023 Feb 28;52(1):20. doi: 10.1186/s40463-022-00599-1.
- Individual participant dataSharing planned: No. Individual participant data (consent form (anonymized), study protocol) will be shared upon reasonable request after publication
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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 Le, MD 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 Eustachian tube dilation in people with Eustachian Tube Dysfunction and Eustachian Tube Dysfunction of Both Ears, 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 26 Oct 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Succesfull procedure (time frame: 20 minutes). 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 NCT04809753, 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 26 Oct 2022.