Trials / Withdrawn
WithdrawnNCT02631187
Feasibility Study of Balloon Eustachian Tuboplasty (BET)
Feasibility Study of Balloon Eustachian Tuboplasty (BET) for Grade 2 and 3 Pars Tensa Retractions
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University Hospital Plymouth NHS Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Bielefeld balloon | Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2017-03-01
- Completion
- 2017-03-01
- First posted
- 2015-12-16
- Last updated
- 2017-11-17
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02631187. Inclusion in this directory is not an endorsement.