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Feasibility Study of Balloon Eustachian Tuboplasty (BET)

NCT02631187 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-11-17

No results posted yet for this study

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). 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

Interventions

DEVICE

Bielefeld balloon

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

Sponsors & Collaborators

  • University Hospital Plymouth NHS Trust

    lead OTHER

Principal Investigators

  • James Rainsbury, BMBS MSc FRCS · University Hospital Plymouth NHS Trust

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02631187 on ClinicalTrials.gov