Feasibility Study of Balloon Eustachian Tuboplasty (BET)

University Hospital Plymouth NHS Trust

Status: Withdrawn

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

Treatments: Device: Bielefeld balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02631187

15/P/164

Details and patient eligibility

About

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)).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Balloon Eustachian Tuboplasty

Experimental group

Description:

Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic

Treatment:

Device: Bielefeld balloon