Eustachian Tube DisorderNCT02123277
Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube
A study testing Balloon catheter for the Eustachian tube in people with Eustachian Tube Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before and after the eustachian tube dilatation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Eustachian Tube Disorder
- What is being tested?
- Balloon catheter for the Eustachian tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between 20 and 80 years old
- tubal score lower than 5
- patients who already used reference medical treatment
Who cannot join
- patients who already do a major surgery of middle ear
- tympanic perforation
- pregnant or breastfeeding woman.
- patients who can't be follow during 14 months
Trial locations and contacts
1 site in 1 country.
About this study
The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before and after the eustachian tube dilatation.
Read the detailed description
The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before the intervention and 12 months after the eustachian tube dilatation.
This patients are refractory to the reference medical treatment.
- Conditions
- Eustachian Tube Disorder
- Being tested
- Balloon catheter for the Eustachian tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon catheter for the Eustachian tubeDevice
Balloon catheter is inserted in the Eustachian tube to dilate it.
| Study group | Role | What they receive |
|---|---|---|
| concept proof | Experimental | Balloon catheter for the Eustachian tube Receives: Device: Balloon catheter for the Eustachian tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tubal score
Measured: at 1st day, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eustachian Tube DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic VENAIL, Principal investigator, CHRU Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123277
- Sponsor's protocol ID
- 9259
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2014
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schmitt D, Akkari M, Mura T, Mondain M, Uziel A, Venail F. Medium-term assessment of Eustachian tube function after balloon dilation. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Apr;135(2):105-110. doi: 10.1016/j.anorl.2017.09.008. Epub 2017 Dec 28.
PubMed 29289487Swords 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 40008607Kaderbay A, Karkas A, Schmitt D, Mura T, Lavieille JP, Venail F. Balloon dilation for persistent unilateral chronic obstructive Eustachian tube dysfunction is effective: a prospective multicentre study. Eur Arch Otorhinolaryngol. 2023 Mar;280(3):1101-1109. doi: 10.1007/s00405-022-07578-2. Epub 2022 Aug 6.
PubMed 35932313
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube
- ClinicalTrials.gov ID
- NCT02123277
- Acronym / sponsor ID
- 9259
- Conditions
- Eustachian Tube Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Apr 2014 (estimated)
- 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 study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before and after the eustachian tube dilatation.
Detailed description
The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before the intervention and 12 months after the eustachian tube dilatation.
This patients are refractory to the reference medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| concept proof | Experimental | Device: Balloon catheter for the Eustachian tubeBalloon catheter for the Eustachian tube |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients between 20 and 80 years old
- tubal score lower than 5
- patients who already used reference medical treatment
Key exclusion criteria (4 listed)
- patients who already do a major surgery of middle ear
- tympanic perforation
- pregnant or breastfeeding woman.
- patients who can't be follow during 14 months
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 catheter for the Eustachian tubeBalloon catheter is inserted in the Eustachian tube to dilate it. | Device | concept proof |
Primary outcome
Change in Tubal score
Time frame: at 1st day, and 2 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 15 Jun 2026.
- Results publication: PubMed 29289487Schmitt D, Akkari M, Mura T, Mondain M, Uziel A, Venail F. Medium-term assessment of Eustachian tube function after balloon dilation. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Apr;135(2):105-110. doi: 10.1016/j.anorl.2017.09.008. Epub 2017 Dec 28.
- 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.
- Derived from this study: PubMed 35932313Kaderbay A, Karkas A, Schmitt D, Mura T, Lavieille JP, Venail F. Balloon dilation for persistent unilateral chronic obstructive Eustachian tube dysfunction is effective: a prospective multicentre study. Eur Arch Otorhinolaryngol. 2023 Mar;280(3):1101-1109. doi: 10.1007/s00405-022-07578-2. Epub 2022 Aug 6.
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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.
Frederic VENAIL principal investigator
CHRU Montpellier
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 catheter for the Eustachian tube in people with Eustachian Tube Disorder, run by University Hospital, Montpellier at 1 site in France.
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 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: finished, as of the sponsor's last update on 15 Jun 2026. 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 France. 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?
Change in Tubal score (time frame: at 1st day, and 2 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 NCT02123277, which also lists 3 linked publications.
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 15 Jun 2026.