Chronic Eustachian Tube DysfunctionNCT03556215
Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
A study testing Eustachian tube dilatation device and Myringotomy in people with Chronic Eustachian Tube Dysfunction and Chronic Recurrent Otitis Media, run by University Hospital Ostrava at 2 sites in Czechia.
Trial summary
The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Eustachian Tube Dysfunction, Chronic Recurrent Otitis Media, Effusion After Tympanostomy
- What is being tested?
- Eustachian tube dilatation device and Myringotomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 May 2016to 30 Nov 2020
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with chronic Eustachian tube dysfunction lasting more than 6 months, with or without recurrence of chronic otitis media with effusion after tympanostomy
Who cannot join
- anatomic obstruction in nasopharynx
- nasopharyngeal cancer
- head and neck cancer
- other middle ear surgery except for myringotomy or tympanostomy
- chronic suppurative otitis media
- patients who could not undergo general anesthesia
- patients who did not give consent to be included in the study
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
University Hospital Hradec Králové
Hradec Králové, Hradec Králové Region, 500 05
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
About this study
The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group.
Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. Subgroups will be compared in order to identify treatment effect in particular subgroups.
Read the detailed description
The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group.
Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. The otomicro(endo)scopy, symptoms severity according to VAS (Visual Analogue Pain Scale), ETDQ-7 (Eustachian Tube Dysfunction Questionnaire) questionnaire, tympanometry, audiometry and the possibility of Valsalva and Toynbee maneuver will be used to evaluate the effect of balloon ET dilatation. Only patients with standard treatment failure will be included in the study. Tuboplasty with and without myringotomy will be performed (and compared) in patients with chronic otitis media with effusion. Subgroups will be compared in order to find patients who could profit from the treatments the most.
- Conditions
- Chronic Eustachian Tube Dysfunction, Chronic Recurrent Otitis Media, Effusion After Tympanostomy
- Being tested
- Eustachian tube dilatation device, Myringotomy
- Keywords
- otitis media with effusion, balloon tuboplasty, Eustachian tube, Eustachian tube dysfunction
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eustachian tube dilatation deviceDevice
Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.
MyringotomyProcedure or surgery
Myringotomy will be performed using a standard procedure.
| Study group | Role | What they receive |
|---|---|---|
| Effusion, Eustachian tube dilatation device and myringotomy | Experimental | Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty, and myringotomy Receives: Device: Eustachian tube dilatation device; Procedure: Myringotomy |
| Effusion, Eustachian tube dilatation device | Experimental | Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty only (no myringotomy) Receives: Device: Eustachian tube dilatation device |
| No effusion, Eustachian tube dilatation device | Experimental | Patients with chronic Eustachian tube dysfunction and airy middle ear (without otitis media with effusion), Eustachian tube dilatation device, no myringotomy Receives: Device: Eustachian tube dilatation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Otomicro(endo)scopy
Otomicro(endo)scopy will be used to assess the presence or absence of effusion.
Measured: 36 months
Secondary outcomes (6)
Symptoms severity according to Visual Analogue Scale
Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: 36 months
ETDQ-7 questionnaire
The patients will be asked to fill-in the Eustachian Tube Dysfunction Questionnaire in order to assess the symptoms of Eustachian Tube Dysfunction (ETD). The ETDQ-7 is a valid and reliable symptom score for use in adult patients with ETD. The ETDQ-7 tool consists of seven items with a scale of graduated responses ranging from 1 to 7, with "1" corresponding to the absence of the suggested symptom and "7", to maximum symptom severity.
Measured: 36 months
Tympanometry
Type of tympanometry curve (A, B, C) according to Joerger et al.
Measured: 36 months
Audiometry
Hearing loss according to WHO classification (mild, moderate, severe).
Measured: 36 months
Tubomanometry
Assessment of opening pressure in Eustachian tube in mmHg.
Measured: 36 months
Possibility of Valsalva and Toynbee manoeuvre
The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 May 2016
- Primary completion31 May 2020
- Study completion30 Nov 2020
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 Chronic 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional parallel randomized controlled prospective trial
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Hradec Kralove
- Responsible party
- Sponsor
- Investigators
- Pavel Komínek, prof.,MD,Ph.D.,MBA, Study chair, University Hospital OstravaMartin Formánek, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556215
- Sponsor's protocol ID
- FNO-ENT-BET
- Other IDs
- MH CZ - DRO - FNOs/2016
- Status last verified
- Dec 2022
- First submitted
- 20 May 2018
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not decided to make individual participant data available to other researchers.
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 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
- ClinicalTrials.gov ID
- NCT03556215
- Acronym / sponsor ID
- FNO-ENT-BET
- Conditions
- Chronic Eustachian Tube Dysfunction, Chronic Recurrent Otitis Media, Effusion After Tympanostomy
- Keywords
- otitis media with effusion, balloon tuboplasty, Eustachian tube, Eustachian tube dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University Hospital Hradec Kralove
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 14 Jun 2018 (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 prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group.
Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. Subgroups will be compared in order to identify treatment effect in particular subgroups.
Detailed description
The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group.
Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. The otomicro(endo)scopy, symptoms severity according to VAS (Visual Analogue Pain Scale), ETDQ-7 (Eustachian Tube Dysfunction Questionnaire) questionnaire, tympanometry, audiometry and the possibility of Valsalva and Toynbee maneuver will be used to evaluate the effect of balloon ET dilatation. Only patients with standard treatment failure will be included in the study. Tuboplasty with and without myringotomy will be performed (and compared) in patients with chronic otitis media with effusion. Subgroups will be compared in order to find patients who could profit from the treatments the most.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional parallel randomized controlled prospective trial
| Arm | Type | Receives |
|---|---|---|
| Effusion, Eustachian tube dilatation device and myringotomy | Experimental | Device: Eustachian tube dilatation device, Procedure: MyringotomyPatients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty, and myringotomy |
| Effusion, Eustachian tube dilatation device | Experimental | Device: Eustachian tube dilatation devicePatients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty only (no myringotomy) |
| No effusion, Eustachian tube dilatation device | Experimental | Device: Eustachian tube dilatation devicePatients with chronic Eustachian tube dysfunction and airy middle ear (without otitis media with effusion), Eustachian tube dilatation device, no myringotomy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with chronic Eustachian tube dysfunction lasting more than 6 months, with or without recurrence of chronic otitis media with effusion after tympanostomy
Key exclusion criteria (7 listed)
- anatomic obstruction in nasopharynx
- nasopharyngeal cancer
- head and neck cancer
- other middle ear surgery except for myringotomy or tympanostomy
- chronic suppurative otitis media
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 dilatation deviceBalloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device. | Device | Effusion, Eustachian tube dilatation device, Effusion, Eustachian tube dilatation device and myringotomy, No effusion, Eustachian tube dilatation device |
| MyringotomyMyringotomy will be performed using a standard procedure. | Procedure or surgery | Effusion, Eustachian tube dilatation device and myringotomy |
Primary outcome
Otomicro(endo)scopy
Time frame: 36 months
Otomicro(endo)scopy will be used to assess the presence or absence of effusion.
6 secondary outcomes
Symptoms severity according to Visual Analogue Scale
Time frame: 36 months
ETDQ-7 questionnaire
Time frame: 36 months
Tympanometry
Time frame: 36 months
Audiometry
Time frame: 36 months
Tubomanometry
Time frame: 36 months
Possibility of Valsalva and Toynbee manoeuvre
Time frame: 36 months
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 7 Dec 2022.
- 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: Undecided. The investigators have not decided to make individual participant data available to other researchers.
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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.
Pavel Komínek, prof.,MD,Ph.D.,MBA study chair
University Hospital Ostrava
Martin Formánek, MD principal investigator
University Hospital Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eustachian tube dilatation device and Myringotomy in people with Chronic Eustachian Tube Dysfunction and Chronic Recurrent Otitis Media, run by University Hospital Ostrava at 2 sites in Czechia.
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 1 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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?
Otomicro(endo)scopy (time frame: 36 months). 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 NCT03556215, 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 7 Dec 2022.