BET for pars tensa retractions

  • Research type

    Research Study

  • Full title

    Feasibility study of Balloon Eustachian Tuboplasty (BET) for grade 2 and 3 pars tensa retractions

  • IRAS ID

    189163

  • Contact name

    JW Rainsbury

  • Contact email

    james.rainsbury@nhs.net

  • Sponsor organisation

    Plymouth Hospitals NHS Trust

  • Clinicaltrials.gov Identifier

    NCT02631187

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Retraction pockets (RPs) in the ear drum (tympanic membrane; TM) can progress to cause hearing loss, recurrent infections, or potentially destructive skin cysts in the ear. The main reason that RPs form is thought to be inadequate function of the Eustachian Tube (ET) that connects the ear to the back of the nose. Currently, ENT surgeons do not have an effective way to treat ET dysfunction, so RPs are treated with a variety of methods, including surgical reconstruction of the TM (tympanoplasty), although no treatment has been definitively proven to be effective. A promising treatment for other symptoms of ET dysfunction is to stretch the ET using a balloon passed in through the nose (Balloon Eustachian Tuboplasty; BET). This study aims to assess the feasibility of a larger Randomised Control Trial of BET for intermediate stage RPs of the ear drum.

  • REC name

    South West - Cornwall & Plymouth Research Ethics Committee

  • REC reference

    16/SW/0017

  • Date of REC Opinion

    1 Feb 2016

  • REC opinion

    Favourable Opinion