Clinical trial NCT02631187: Feasibility Study of Balloon Eustachian Tuboplasty (BET)
Official title: Feasibility Study of Balloon Eustachian Tuboplasty (BET) for Grade 2 and 3 Pars Tensa Retractions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Retraction of the Pars Tensa of the Tympanic Membrane
Eustachian Tube Dysfunction
Retraction Pocket of the Tympanic Membrane
Keywords: Grade 2 retraction of the pars tensa of the tympanic membrane
Grade 3 retraction of the pars tensa of the tympanic membrane
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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)).


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: 6 months
measure: Patient Focus Group
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
Secondary outcomes:
measure: Demand
timeFrame: 1 year
measure: Cost analysis of treatment
timeFrame: 1 year
measure: Comparison of otoendoscopy images
timeFrame: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
measure: Ability to perform Valsalva
timeFrame: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
measure: Tympanometry
timeFrame: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
measure: pure-tone average (PTA) hearing loss
timeFrame: Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
state: Devon
Study officials:
affiliation: University Hospital Plymouth NHS Trust
name: James Rainsbury, BMBS MSc FRCS
role: PRINCIPAL_INVESTIGATOR
References: