Feasibility Study of Balloon Eustachian Tuboplasty (BET)

Study Overview
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Brief Summary
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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)).

Official Title
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Feasibility Study of Balloon Eustachian Tuboplasty (BET) for Grade 2 and 3 Pars Tensa Retractions

Conditions
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Retraction of the Pars Tensa of the Tympanic Membrane, Eustachian Tube Dysfunction, Retraction Pocket of the Tympanic Membrane

Intervention / Treatment
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* Device: Bielefeld balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients over 18 years old with grade 2-3 retraction pocket of the tympanic membrane as assessed by study clinician. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon Eustachian Tuboplasty<br>Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic | Device: Bielefeld balloon<br>* Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demand | Demand assessed by recruitment rate | 1 year | 
| Cost analysis of treatment | Cost analysis of BET vs. cartilage tympanoplasty | 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. | 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. | 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. | 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 | Assessed pre-intervention and post-intervention at 2 weeks and 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Grade 2 retraction of the pars tensa of the tympanic membrane, Grade 3 retraction of the pars tensa of the tympanic membrane