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Feasibility Study of Balloon Eustachian Tuboplasty (BET)

NCT ID: NCT02631187

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

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)).

Detailed Description

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Conditions

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

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Balloon Eustachian Tuboplasty

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

Group Type EXPERIMENTAL

Bielefeld balloon

Intervention Type DEVICE

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

Interventions

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Bielefeld balloon

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Plymouth NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Rainsbury, BMBS MSc FRCS

Role: PRINCIPAL_INVESTIGATOR

University Hospital Plymouth NHS Trust

Locations

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Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 40008607 (View on PubMed)

Other Identifiers

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15/P/164

Identifier Type: -

Identifier Source: org_study_id