Retraction of the Pars Tensa of the Tympanic MembraneBETNCT02631187
Feasibility Study of Balloon Eustachian Tuboplasty (BET)
A study testing Bielefeld balloon in people with Retraction of the Pars Tensa of the Tympanic Membrane and Eustachian Tube Dysfunction, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
This is a study that aims to evaluate the feasibility of undertaking a United Kingdom (UK) multi-centre randomised controlled trial of BET for the treatment of moderate (grade 2 or 3) retraction pockets (RPs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retraction of the Pars Tensa of the Tympanic Membrane, Eustachian Tube Dysfunction, Retraction Pocket of the Tympanic Membrane
- What is being tested?
- Bielefeld balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 18 years old with grade 2-3 retraction pocket of the tympanic membrane as assessed by study clinician.
Who cannot join
- Craniofacial abnormalities (assessed by history and examination)
- Cholesteatoma (assessed by history, otoscopy, tympanogram, PTA)
- Nasopharyngeal tumours (assessed by flexible nasendoscopy)
- Adenoid hypertrophy (assessed by flexible nasendoscopy)
- Patulous ET (assessed by history, otoscopy and tympanogram)
- Previous middle ear surgery (assessed by history and otoscopy)
- Concurrent use of anticoagulant medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8DH
About this study
Official title: Feasibility Study of Balloon Eustachian Tuboplasty (BET) for Grade 2 and 3 Pars Tensa Retractions
This is a study that aims to evaluate the feasibility of undertaking a United Kingdom (UK) multi-centre randomised controlled trial of BET for the treatment of moderate (grade 2 or 3) retraction pockets (RPs). This future study will aim to address the question: Does BET improve symptoms scores, audiometry and otoscopic appearance of Grade 2-3 pars tensa RPs in adult patients?
Currently conservative treatments for this condition has been shown to be ineffective; there is a significant risk of progression to hearing loss or more serious complications in untreated retraction pockets; and the surgical treatments available to us in the UK not only have a number of risks and drawbacks, but also do not aim to treat the underlying cause (Eustachian Tube dysfunction (ETD)).
- Conditions
- Retraction of the Pars Tensa of the Tympanic Membrane, Eustachian Tube Dysfunction, Retraction Pocket of the Tympanic Membrane
- Being tested
- Bielefeld balloon
- Keywords
- Grade 2 retraction of the pars tensa of the tympanic membrane, Grade 3 retraction of the pars tensa of the tympanic membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bielefeld balloonDevice
Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic
| Study group | Role | What they receive |
|---|---|---|
| Balloon Eustachian Tuboplasty | Experimental | Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic Receives: Device: Bielefeld balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Acceptability of the procedure, which will be assessed with pre- and post-procedure using the the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7).
Measured: 6 months
Patient Focus Group
Thematic analysis of Patient Focus Group discussions. Standardised questions and focus group discussion with patients with (i) un-operated asymptomatic Retraction Pockets (RPs), (ii) un-operated symptomatic RPs, (iii) RPs treated with cartilage tympanoplasty, and (iv) RPs treated with BET. These will qualitatively assess (as appropriate) positive and negative aspects of patient experience, such as living with the RP, the procedure itself, their recovery, any after effects, and participating in the study. Focus groups will consist of 6 patients in each group.
Measured: 6 months
Complications
An assessment of the number of complications in the 20 participants undergoing BET will also be performed as a marker of safety of the procedure.
Measured: 6 months
Secondary outcomes (6)
Demand
Demand assessed by recruitment rate
Measured: 1 year
Cost analysis of treatment
Cost analysis of BET vs. cartilage tympanoplasty
Measured: 1 year
Comparison of otoendoscopy images
Comparison of otoendoscopy images by two experienced observers and computer software (ImageJ). Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Measured: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Ability to perform Valsalva
Ability to perform Valsalva measured as always, sometimes or never. Assessed pre-intervention and post-intervention at 2 weeks and 6.
Measured: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Tympanometry
Tympanometry (peak middle ear pressure and compliance, and Jerger grade (Improved, unchanged, worse)). Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Measured: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
pure-tone average (PTA) hearing loss
PTA (air conduction at 0.25, 0.5, 1, 2, 3, 4, 6, 8kHz; bone conduction at 0.5, 1, 2, 3, 4 kHz) with calculation of air bone gap at 0.5, 1, 2, 3 and 4kHz. Assessed pre-intervention and post-intervention at 2 weeks and 6 months
Measured: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Inability to recruit any trial partcipants
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 Retraction of the Pars Tensa of the Tympanic MembraneStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Rainsbury, BMBS MSc FRCS, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631187
- Sponsor's protocol ID
- 15/P/164
- Acronym
- BET
- Status last verified
- Oct 2016
- First submitted
- 1 Dec 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Balloon Eustachian Tuboplasty (BET) for Grade 2 and 3 Pars Tensa Retractions
- ClinicalTrials.gov ID
- NCT02631187
- Acronym / sponsor ID
- BET / 15/P/164
- Conditions
- Retraction of the Pars Tensa of the Tympanic Membrane, Eustachian Tube Dysfunction, Retraction Pocket of the Tympanic Membrane
- Keywords
- Grade 2 retraction of the pars tensa of the tympanic membrane, Grade 3 retraction of the pars tensa of the tympanic membrane
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit any trial partcipants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Dec 2015 (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 is a study that aims to evaluate the feasibility of undertaking a United Kingdom (UK) multi-centre randomised controlled trial of BET for the treatment of moderate (grade 2 or 3) retraction pockets (RPs). This future study will aim to address the question: Does BET improve symptoms scores, audiometry and otoscopic appearance of Grade 2-3 pars tensa RPs in adult patients?
Currently conservative treatments for this condition has been shown to be ineffective; there is a significant risk of progression to hearing loss or more serious complications in untreated retraction pockets; and the surgical treatments available to us in the UK not only have a number of risks and drawbacks, but also do not aim to treat the underlying cause (Eustachian Tube dysfunction (ETD)).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balloon Eustachian Tuboplasty | Experimental | Device: Bielefeld balloonBalloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients over 18 years old with grade 2-3 retraction pocket of the tympanic membrane as assessed by study clinician.
Key exclusion criteria (7 listed)
- Craniofacial abnormalities (assessed by history and examination)
- Cholesteatoma (assessed by history, otoscopy, tympanogram, PTA)
- Nasopharyngeal tumours (assessed by flexible nasendoscopy)
- Adenoid hypertrophy (assessed by flexible nasendoscopy)
- Patulous ET (assessed by history, otoscopy and tympanogram)
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 |
|---|---|---|
| Bielefeld balloonBalloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic | Device | Balloon Eustachian Tuboplasty |
Primary outcome
Acceptability
Time frame: 6 months
Acceptability of the procedure, which will be assessed with pre- and post-procedure using the the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7).
Patient Focus Group
Time frame: 6 months
Thematic analysis of Patient Focus Group discussions. Standardised questions and focus group discussion with patients with (i) un-operated asymptomatic Retraction Pockets (RPs), (ii) un-operated symptomatic RPs, (iii) RPs treated with cartilage tympanoplasty, and (iv) RPs treated with BET. These will qualitatively assess (as appropriate) positive and negative aspects of patient experience, such as living with the RP, the procedure itself, their recovery, any after effects, and participating in the study. Focus groups will consist of 6 patients in each group.
Complications
Time frame: 6 months
An assessment of the number of complications in the 20 participants undergoing BET will also be performed as a marker of safety of the procedure.
6 secondary outcomes
Demand
Time frame: 1 year
Cost analysis of treatment
Time frame: 1 year
Comparison of otoendoscopy images
Time frame: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Ability to perform Valsalva
Time frame: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Tympanometry
Time frame: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
pure-tone average (PTA) hearing loss
Time frame: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 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.
- Individual participant dataSharing planned: Undecided
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.
James Rainsbury, BMBS MSc FRCS principal investigator
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bielefeld balloon in people with Retraction of the Pars Tensa of the Tympanic Membrane and Eustachian Tube Dysfunction, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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: withdrawn, as of the sponsor's last update on 17 Nov 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 Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Acceptability (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT02631187, 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 17 Nov 2017.