Balloon Eustachian TuboplastyNCT03440710
The Therapeutic Effect of BET in COM With ETD
A study testing BET in people with Balloon Eustachian Tuboplasty, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
Currently, surgical treatment of patients with chronic otitis media is one of the most important treatment methods. However, the current results show that some patients with eustachian tube dysfunction can't reconstruct the gas-containing structure of the middle ear after operation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Balloon Eustachian Tuboplasty
- What is being tested?
- BET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who need tympanoplasty, with clear diagnosis of chronic otitis media, middle ear cholesteatoma;
- Patients with eustachian tube dysfunction using TMM;
- Subjects or their legal representatives can understand the purpose of the study, show sufficient compliance with the research protocol, and sign the informed consent form.
Who cannot join
- Secondary chronic otitis media (after head and neck cancer radiotherapy);
- Ipsilateral ear recurrence after surgical treatment, requiring secondary surgery;
- Two tympanoplasty surgery;
- Typical allergic rhinitis, nasal endoscopy or imaging studies suggest chronic rhinosinusitis, nasal polyps and other short-term eustachian tube function of a greater impact on the disease;
- poor general health, with severe liver and kidney dysfunction, coagulation disorders, cardiovascular disease, neurological diseases can not tolerate surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200031
About this study
Official title: The Therapeutic Effect of Balloon Eustachian Tuboplasty (BET) in Chronic Otitis Media (COM) With Eustachian Tube Dysfunction (ETD)
Currently, surgical treatment of patients with chronic otitis media is one of the most important treatment methods. However, the current results show that some patients with eustachian tube dysfunction can't reconstruct the gas-containing structure of the middle ear after operation.
This is a randomized controlled trial that aims to evaluate the therapeutic effect of balloon eustachian tuboplasty (BET) for the treatment in chronic otitis media (COM) with eustachian tube dysfunction (ETD). This future study will aim to address the question: Does BET gain better recovery of auditory function and lower recurrence rate in chronic otitis media with eustachian tube dysfunction?
- Conditions
- Balloon Eustachian Tuboplasty
- Being tested
- BET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BETProcedure or surgery
Balloon Eustachian Tuboplasty
| Study group | Role | What they receive |
|---|---|---|
| with BET | Experimental | with BET and Tympanoplast Receives: Procedure: BET |
| without BET | Other | with Tympanoplast only Receives: Procedure: BET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate in chronic otitis media with eustachian tube dysfunction
Recurrence rate in chronic otitis media with eustachian tube dysfunction: with BET vs without BET
Measured: 6months after the surgery
Secondary outcomes (2)
Hearing change in chronic otitis media with eustachian tube dysfunction
Hearing outcome in chronic otitis media with eustachian tube dysfunction: with BET vs without BET
Measured: before the surgery, and 6months after the surgery
The change of Eustachian tube function using TUBOMANOMETRY (TMM)
Eustachian tube function before and after surgery using TUBOMANOMETRY (TMM)
Measured: before the surgery, and 6months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jun 2018 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completion30 Dec 2019 (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 Balloon Eustachian TuboplastyStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440710
- Sponsor's protocol ID
- The Effect of BET in COM
- Status last verified
- Feb 2018
- First submitted
- 11 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Balloon Eustachian Tuboplasty (BET) in Chronic Otitis Media (COM) With Eustachian Tube Dysfunction (ETD)
- ClinicalTrials.gov ID
- NCT03440710
- Acronym / sponsor ID
- The Effect of BET in COM
- Conditions
- Balloon Eustachian Tuboplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 22 Feb 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.
Currently, surgical treatment of patients with chronic otitis media is one of the most important treatment methods. However, the current results show that some patients with eustachian tube dysfunction can't reconstruct the gas-containing structure of the middle ear after operation.
This is a randomized controlled trial that aims to evaluate the therapeutic effect of balloon eustachian tuboplasty (BET) for the treatment in chronic otitis media (COM) with eustachian tube dysfunction (ETD). This future study will aim to address the question: Does BET gain better recovery of auditory function and lower recurrence rate in chronic otitis media with eustachian tube dysfunction?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with BET | Experimental | Procedure: BETwith BET and Tympanoplast |
| without BET | Other | Procedure: BETwith Tympanoplast only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who need tympanoplasty, with clear diagnosis of chronic otitis media, middle ear cholesteatoma;
- Patients with eustachian tube dysfunction using TMM;
- Subjects or their legal representatives can understand the purpose of the study, show sufficient compliance with the research protocol, and sign the informed consent form.
Key exclusion criteria (5 listed)
- Secondary chronic otitis media (after head and neck cancer radiotherapy);
- Ipsilateral ear recurrence after surgical treatment, requiring secondary surgery;
- Two tympanoplasty surgery;
- Typical allergic rhinitis, nasal endoscopy or imaging studies suggest chronic rhinosinusitis, nasal polyps and other short-term eustachian tube function of a greater impact on the disease;
- poor general health, with severe liver and kidney dysfunction, coagulation disorders, cardiovascular disease, neurological diseases can not tolerate surgery.
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 |
|---|---|---|
| BETBalloon Eustachian Tuboplasty | Procedure or surgery | with BET, without BET |
Primary outcome
Recurrence rate in chronic otitis media with eustachian tube dysfunction
Time frame: 6months after the surgery
Recurrence rate in chronic otitis media with eustachian tube dysfunction: with BET vs without BET
2 secondary outcomes
Hearing change in chronic otitis media with eustachian tube dysfunction
Time frame: before the surgery, and 6months after the surgery
The change of Eustachian tube function using TUBOMANOMETRY (TMM)
Time frame: before the surgery, and 6months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- 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: No
Related trials for Balloon Eustachian Tuboplasty
Not yet recruiting
Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease
Eustachian Tube Dysfunction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BET in people with Balloon Eustachian Tuboplasty, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 5 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 22 Feb 2018. 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 China. 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?
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?
Recurrence rate in chronic otitis media with eustachian tube dysfunction (time frame: 6months after the surgery). 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 NCT03440710, 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 22 Feb 2018.