Eustachian Tube DysfunctionNCT02114762
Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction
A study testing Balloon dilation of the Eustachian tube in people with Eustachian Tube Dysfunction, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study evaluates the usefulness and safety of using a balloon to dilate (make larger) the Eustachian tube in adults who have middle-ear disease due to Eustachian tube dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Eustachian Tube Dysfunction
- What is being tested?
- Balloon dilation of the Eustachian tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 30 Apr 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- has functional ventilation tube or a chronic perforation in at least one ear;
- history of Eustachian tube dysfunction and/or otitis media with effusion;
- history of middle-ear effusion at least once;
- otherwise healthy except for possible gastro-esophageal reflux disease (GERD), allergies, sinusitis;
- BMI of less than 35;
- no history of difficult intubation;
- no known family history of malignant hyperthermia.
Who cannot join
- history of adverse reaction to any study-related medication and a suitable alternative is not available;
- current or past history of cancer;
- current or past history of vestibular pathology or cranial base surgery;
- craniofacial dysmorphology (examples: down syndrome, cleft palate);
- pregnancy or "at risk" and not using contraception;
- patulous Eustachian tube;
Show all 12Show fewer
- non-patent nasal cavity;
- adenoids that block the Eustachian tube orifice;
- blood pressure greater than 140/90;
- had experimental drug or procedure in the previous 3 months;
- allergic to eggs, egg products, soy, or soy products;
- previously underwent balloon dilation of the Eustachian tube.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
This study evaluates the usefulness and safety of using a balloon to dilate (make larger) the Eustachian tube in adults who have middle-ear disease due to Eustachian tube dysfunction.
Read the detailed description
The Eustachian tube is a biological tube that connects the back of the nose to the middle ear. It is usually closed but needs to be actively opened by the action of certain muscles during swallowing, yawning, and other activities which keeps the air pressure in the middle ear (the part of the ear behind the eardrum) the same as the air pressure in the environment. If the Eustachian tube does not open during swallowing, the middle-ear pressure progressively decreases and persons may have the feeling of a "stuffed up" and/or "full" middle ear, may have difficulty hearing and/or may develop fluid in their middle ear.
The usual treatment for a Eustachian tube that does not open well is to insert a tiny tube (called a ventilation or tympanostomy tube) into the eardrum to keep the air pressure in the middle ear the same as in the environment. However, those tubes naturally "fall out" over time, and if the Eustachian tube opening function had not improved while they were in place, new tubes will need to be inserted. In the past few years, doctors in the U.S. and Europe described a simple procedure called "balloon dilation of the Eustachian tube" (BDET) or "balloon tuboplasty" that they believe corrects the underlying cause of Eustachian tube dysfunction and resolves its symptoms, signs and consequences. For that procedure, a tiny balloon is inserted into the Eustachian tube, inflated to physically open the Eustachian tube, deflated and then removed. Doctors who have used the method in adults and children with symptoms of Eustachian tube dysfunction reported that BDET is safe and causes a short-term and, perhaps, a long-term resolution of symptoms. However, no one has measured Eustachian tube function before and after the procedure, and it is not known if BDET truly improves that function or not, and if so, how that function is changed.
In this study, we will enroll adult subjects with a tympanostomy tube inserted into at least one eardrum or a chronic perforation in at least one eardrum for physician-diagnosed Eustachian tube dysfunction or middle-ear fluid and document the presence/absence of measurable Eustachian tube dysfunction using standard tests. If present, we will determine if the Eustachian tube dysfunction improves after medical treatment of other diseases known to cause Eustachian tube dysfunction. If the Eustachian tube dysfunction does not significantly improve, we will perform the BDET procedure and measure the change in Eustachian tube function at different times after the procedure.
- Conditions
- Eustachian Tube Dysfunction
- Being tested
- Balloon dilation of the Eustachian tube
- Keywords
- otitis media, eustachian tube, eustachian tube dysfunction, eustachian tube function testing
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon dilation of the Eustachian tubeProcedure or surgery
Also called Balloon tuboplasty
Insert a balloon into one Eaustachian tube and inflate it for up to one minute. The balloon is then removed.
| Study group | Role | What they receive |
|---|---|---|
| Balloon dilation of the Eustachian tube | Experimental | Insertion and inflation of balloon into Eustachian tube for up to 1 minute Receives: Procedure: Balloon dilation of the Eustachian tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eustachian tube function testing
opening pressure, closing pressure, passive resistance
Measured: 1 month post-operatively
Secondary outcomes (3)
Eustachian tube function testing
opening pressure, closing pressure, passive resistance
Measured: 3 months post-operatively
Eustachian tube function testing
opening pressure, closing pressure, passive resistance
Measured: 6 months post-operatively
Eustachian tube function testing
opening pressure, closing pressure, passive resistance
Measured: 4 weeks after beginning medical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion23 Nov 2016
- Study completion30 Apr 2017
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 University of PittsburghThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Cuneyt M. Alper, University of Pittsburgh
- Investigators
- Cuneyt M Alper, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114762
- Sponsor's protocol ID
- PRO13120437
- Other IDs
- R21DC013167
- Status last verified
- Sep 2017
- First submitted
- 7 Apr 2014
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- 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 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction
- ClinicalTrials.gov ID
- NCT02114762
- Acronym / sponsor ID
- PRO13120437
- Conditions
- Eustachian Tube Dysfunction
- Keywords
- otitis media, eustachian tube, eustachian tube dysfunction, eustachian tube function testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Apr 2014 (actual)
- Primary completion
- 23 Nov 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 15 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.
This study evaluates the usefulness and safety of using a balloon to dilate (make larger) the Eustachian tube in adults who have middle-ear disease due to Eustachian tube dysfunction.
Detailed description
The Eustachian tube is a biological tube that connects the back of the nose to the middle ear. It is usually closed but needs to be actively opened by the action of certain muscles during swallowing, yawning, and other activities which keeps the air pressure in the middle ear (the part of the ear behind the eardrum) the same as the air pressure in the environment. If the Eustachian tube does not open during swallowing, the middle-ear pressure progressively decreases and persons may have the feeling of a "stuffed up" and/or "full" middle ear, may have difficulty hearing and/or may develop fluid in their middle ear.
The usual treatment for a Eustachian tube that does not open well is to insert a tiny tube (called a ventilation or tympanostomy tube) into the eardrum to keep the air pressure in the middle ear the same as in the environment. However, those tubes naturally "fall out" over time, and if the Eustachian tube opening function had not improved while they were in place, new tubes will need to be inserted. In the past few years, doctors in the U.S. and Europe described a simple procedure called "balloon dilation of the Eustachian tube" (BDET) or "balloon tuboplasty" that they believe corrects the underlying cause of Eustachian tube dysfunction and resolves its symptoms, signs and consequences. For that procedure, a tiny balloon is inserted into the Eustachian tube, inflated to physically open the Eustachian tube, deflated and then removed. Doctors who have used the method in adults and children with symptoms of Eustachian tube dysfunction reported that BDET is safe and causes a short-term and, perhaps, a long-term resolution of symptoms. However, no one has measured Eustachian tube function before and after the procedure, and it is not known if BDET truly improves that function or not, and if so, how that function is changed.
In this study, we will enroll adult subjects with a tympanostomy tube inserted into at least one eardrum or a chronic perforation in at least one eardrum for physician-diagnosed Eustachian tube dysfunction or middle-ear fluid and document the presence/absence of measurable Eustachian tube dysfunction using standard tests. If present, we will determine if the Eustachian tube dysfunction improves after medical treatment of other diseases known to cause Eustachian tube dysfunction. If the Eustachian tube dysfunction does not significantly improve, we will perform the BDET procedure and measure the change in Eustachian tube function at different times after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balloon dilation of the Eustachian tube | Experimental | Procedure: Balloon dilation of the Eustachian tubeInsertion and inflation of balloon into Eustachian tube for up to 1 minute |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- has functional ventilation tube or a chronic perforation in at least one ear;
- history of Eustachian tube dysfunction and/or otitis media with effusion;
- history of middle-ear effusion at least once;
- otherwise healthy except for possible gastro-esophageal reflux disease (GERD), allergies, sinusitis;
- BMI of less than 35;
Key exclusion criteria (12 listed)
- history of adverse reaction to any study-related medication and a suitable alternative is not available;
- current or past history of cancer;
- current or past history of vestibular pathology or cranial base surgery;
- craniofacial dysmorphology (examples: down syndrome, cleft palate);
- pregnancy or "at risk" and not using contraception;
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 tubeAlso: Balloon tuboplastyInsert a balloon into one Eaustachian tube and inflate it for up to one minute. The balloon is then removed. | Procedure or surgery | Balloon dilation of the Eustachian tube |
Primary outcome
Eustachian tube function testing
Time frame: 1 month post-operatively
opening pressure, closing pressure, passive resistance
3 secondary outcomes
Eustachian tube function testing
Time frame: 3 months post-operatively
Eustachian tube function testing
Time frame: 6 months post-operatively
Eustachian tube function testing
Time frame: 4 weeks after beginning medical treatment
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 11 Sep 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.
Cuneyt M Alper, MD principal investigator
University of Pittsburgh
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 University of Pittsburgh at 1 site in United States.
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 7 inclusion and 12 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 11 Sep 2017. 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 United States. 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?
Eustachian tube function testing (time frame: 1 month post-operatively). 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 NCT02114762, 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 11 Sep 2017.