Eustachian Tube DysfunctionNCT03322579
Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge
A study testing Balloon dilatation Eustachian tuboplasty in people with Eustachian Tube Dysfunction, run by Hillel Yaffe Medical Center.
Trial summary
Balloon dilatation Eustachian tuboplasty has recently become a promising procedure for the treatment of refractory dilatory dysfunction of the Eustachian tube. Eustachian tube (ET) comprises an osseous intratemporal portion and a cartilaginous nasopharyngeal portion. 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 dilatation Eustachian tuboplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Dec 2018
- 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
- Adults (over 18 years) with a diagnosis of Eustachian tube dysfunction based on symptoms and abnor-mal tympanogram.
- OME and/or TM atelectasis
- Type B or C tympanograms
- Inability to inflate middle ears by Valsalva maneuver.
- Patients performed tympanocentesis and patients underwent tube insertion will be included.
Who cannot join
- Children less than 18 years old.
- Patients with an active infection.
- Patients with craniofacial abnormalities.
- Pregnancy?
About this study
Balloon dilatation Eustachian tuboplasty has recently become a promising procedure for the treatment of refractory dilatory dysfunction of the Eustachian tube.
Eustachian tube (ET) comprises an osseous intratemporal portion and a cartilaginous nasopharyngeal portion. It functions in pressure equalization, middle ear protection and clearance. Eustachian tube function can be adversely affected by viral and bacterial infections, adenoid disease, craniofacial anomalies, neoplasm, genetic predisposition, sinonasal disease and gastroesophageal reflux, leading to Eustachian tube dysfunction. Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.
Read more
The surgical technique, the optimal balloon diameter, pressure or duration of inflation are variable in the literature.
Even though the current data shows promising results and a potential benefit of this procedure, further evaluation is still needed in order to establish a higher level of evidence of efficacy and safety.
Read the detailed description
Balloon dilatation Eustachian tuboplasty has recently become a promising procedure for the treatment of refractory dilatory dysfunction of the Eustachian tube.
Eustachian tube (ET) comprises an osseous intratemporal portion and a cartilaginous nasopharyngeal portion. It functions in pressure equalization, middle ear protection and clearance. Eustachian tube function can be adversely affected by viral and bacterial infections, adenoid disease, craniofacial anomalies, neoplasm, genetic predisposition, sinonasal disease and gastroesophageal reflux, leading to Eustachian tube dysfunction.
it is now well known that the site of pathology is usually in the cartilaginous portion and not within the osseus portion.
Chronic dilatory dysfunction of the Eustachian tube is estimated to be 1% of the adult population. Current medical and surgical treatment options for this pathophysiological disorder is still unsatisfactory, including nasal decongestants, topical and systematic corticosteroids, antihistamines and multiple insertions of ventilation tubes leading to complications.
ET dysfunction can lead to impaired quality of life due to persistent sensation of ear fullness, ear pain and inability to tolerate air travel, diving or other activities. With time, Eustachian tube dysfunction, if left untreated can lead to complications such as conductive hearing loss and cholesteatoma formation. Recently, numerous researches have investigated the role of balloon tuboplasty. This procedure aims to ventilate and drain the middle ear by improving the physiological function of the eustachian tube and treating chronic refractory eustachian tube dysfunction.
Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.
The surgical technique, the optimal balloon diameter, pressure or duration of inflation are variable in the literature.
Both cadaveric and clinical studies where done. Cadaveric studies revealed no evidence of fractures to the cartilaginous or bony lumen, and no damage to the internal carotid artery. Several clinical studies and many others that confirm the safety of eustachian tube balloon dilation and consider it as a potential solution for chronic eustachian tube dysfunction. A systematic review preformed in 2014 showed no adverse outcomes in 103 patients who had undergone balloon dilation of the Eustachian tube. Another more recent systematic review in 2016 that included nine prospective studies, describing 713 eustachian tube balloon dilations in 474 patients confirm the safety of eustachian tube balloon dilation.
In September 2016 the ACCLARENT AERA™ Eustachian Tube Balloon Dilation System, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of Eustachian Tube Dysfunction (ETD) and was permitted for marketing.
Even though the current data shows promising results and a potential benefit of this procedure, further evaluation is still needed in order to establish a higher level of evidence of efficacy and safety.
- Conditions
- Eustachian Tube Dysfunction
- Being tested
- Balloon dilatation Eustachian tuboplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon dilatation Eustachian tuboplastyDevice
Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Eustachian tube dysfunction | Experimental | Not described Receives: Device: Balloon dilatation Eustachian tuboplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in eustachian tube function
Otoscopy
Measured: 1,3,6 and 12 month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study startNov 2017 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Unilateral or bilateral balloon catheter dilation will be performed on patients with eustachian tube dysfunction
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322579
- Sponsor's protocol ID
- 0034-17
- Status last verified
- Oct 2017
- First submitted
- 28 Mar 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge
- ClinicalTrials.gov ID
- NCT03322579
- Acronym / sponsor ID
- 0034-17
- Conditions
- Eustachian Tube Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Nov 2017 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Oct 2017 (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.
Balloon dilatation Eustachian tuboplasty has recently become a promising procedure for the treatment of refractory dilatory dysfunction of the Eustachian tube.
Eustachian tube (ET) comprises an osseous intratemporal portion and a cartilaginous nasopharyngeal portion. It functions in pressure equalization, middle ear protection and clearance. Eustachian tube function can be adversely affected by viral and bacterial infections, adenoid disease, craniofacial anomalies, neoplasm, genetic predisposition, sinonasal disease and gastroesophageal reflux, leading to Eustachian tube dysfunction. Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.
The surgical technique, the optimal balloon diameter, pressure or duration of inflation are variable in the literature.
Even though the current data shows promising results and a potential benefit of this procedure, further evaluation is still needed in order to establish a higher level of evidence of efficacy and safety.
Detailed description
Balloon dilatation Eustachian tuboplasty has recently become a promising procedure for the treatment of refractory dilatory dysfunction of the Eustachian tube.
Eustachian tube (ET) comprises an osseous intratemporal portion and a cartilaginous nasopharyngeal portion. It functions in pressure equalization, middle ear protection and clearance. Eustachian tube function can be adversely affected by viral and bacterial infections, adenoid disease, craniofacial anomalies, neoplasm, genetic predisposition, sinonasal disease and gastroesophageal reflux, leading to Eustachian tube dysfunction.
it is now well known that the site of pathology is usually in the cartilaginous portion and not within the osseus portion.
Chronic dilatory dysfunction of the Eustachian tube is estimated to be 1% of the adult population. Current medical and surgical treatment options for this pathophysiological disorder is still unsatisfactory, including nasal decongestants, topical and systematic corticosteroids, antihistamines and multiple insertions of ventilation tubes leading to complications.
ET dysfunction can lead to impaired quality of life due to persistent sensation of ear fullness, ear pain and inability to tolerate air travel, diving or other activities. With time, Eustachian tube dysfunction, if left untreated can lead to complications such as conductive hearing loss and cholesteatoma formation. Recently, numerous researches have investigated the role of balloon tuboplasty. This procedure aims to ventilate and drain the middle ear by improving the physiological function of the eustachian tube and treating chronic refractory eustachian tube dysfunction.
Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.
The surgical technique, the optimal balloon diameter, pressure or duration of inflation are variable in the literature.
Both cadaveric and clinical studies where done. Cadaveric studies revealed no evidence of fractures to the cartilaginous or bony lumen, and no damage to the internal carotid artery. Several clinical studies and many others that confirm the safety of eustachian tube balloon dilation and consider it as a potential solution for chronic eustachian tube dysfunction. A systematic review preformed in 2014 showed no adverse outcomes in 103 patients who had undergone balloon dilation of the Eustachian tube. Another more recent systematic review in 2016 that included nine prospective studies, describing 713 eustachian tube balloon dilations in 474 patients confirm the safety of eustachian tube balloon dilation.
In September 2016 the ACCLARENT AERA™ Eustachian Tube Balloon Dilation System, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of Eustachian Tube Dysfunction (ETD) and was permitted for marketing.
Even though the current data shows promising results and a potential benefit of this procedure, further evaluation is still needed in order to establish a higher level of evidence of efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Unilateral or bilateral balloon catheter dilation will be performed on patients with eustachian tube dysfunction
| Arm | Type | Receives |
|---|---|---|
| Patients with Eustachian tube dysfunction | Experimental | Device: Balloon dilatation Eustachian tuboplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (over 18 years) with a diagnosis of Eustachian tube dysfunction based on symptoms and abnor-mal tympanogram.
- OME and/or TM atelectasis
- Type B or C tympanograms
- Inability to inflate middle ears by Valsalva maneuver.
- Patients performed tympanocentesis and patients underwent tube insertion will be included.
Key exclusion criteria (4 listed)
- Children less than 18 years old.
- Patients with an active infection.
- Patients with craniofacial abnormalities.
- Pregnancy?
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 dilatation Eustachian tuboplastyEustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed. | Device | Patients with Eustachian tube dysfunction |
Primary outcome
The change in eustachian tube function
Time frame: 1,3,6 and 12 month post procedure
Otoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon dilatation Eustachian tuboplasty in people with Eustachian Tube Dysfunction, run by Hillel Yaffe Medical Center.
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 4 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: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The change in eustachian tube function (time frame: 1,3,6 and 12 month post procedure). 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 NCT03322579, 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 2017.