Feasibility Study of Balloon Eustachian Tuboplasty (BET) (BET)

Feasibility Study of Balloon Eustachian Tuboplasty (BET) for Grade 2 and 3 Pars Tensa Retractions

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)).

Study Overview

• Status: Withdrawn
• Conditions: Eustachian Tube Dysfunction; Retraction of the Pars Tensa of the Tympanic Membrane; Retraction Pocket of the Tympanic Membrane
• Intervention / Treatment: Device: Bielefeld balloon

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Plymouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Balloon Eustachian Tuboplasty; Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic	Device: Bielefeld balloon; Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Acceptability of the procedure, which will be assessed with pre- and post-procedure using the the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7).	6 months
Patient Focus Group	Thematic analysis of Patient Focus Group discussions. Standardised questions and focus group discussion with patients with (i) un-operated asymptomatic Retraction Pockets (RPs), (ii) un-operated symptomatic RPs, (iii) RPs treated with cartilage tympanoplasty, and (iv) RPs treated with BET. These will qualitatively assess (as appropriate) positive and negative aspects of patient experience, such as living with the RP, the procedure itself, their recovery, any after effects, and participating in the study. Focus groups will consist of 6 patients in each group.	6 months
Complications	An assessment of the number of complications in the 20 participants undergoing BET will also be performed as a marker of safety of the procedure.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demand	Demand assessed by recruitment rate	1 year
Cost analysis of treatment	Cost analysis of BET vs. cartilage tympanoplasty	1 year
Comparison of otoendoscopy images	Comparison of otoendoscopy images by two experienced observers and computer software (ImageJ). Assessed pre-intervention and post-intervention at 2 weeks and 6 months.	Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Ability to perform Valsalva	Ability to perform Valsalva measured as always, sometimes or never. Assessed pre-intervention and post-intervention at 2 weeks and 6.	Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
Tympanometry	Tympanometry (peak middle ear pressure and compliance, and Jerger grade (Improved, unchanged, worse)). Assessed pre-intervention and post-intervention at 2 weeks and 6 months.	Assessed pre-intervention and post-intervention at 2 weeks and 6 months.
pure-tone average (PTA) hearing loss	PTA (air conduction at 0.25, 0.5, 1, 2, 3, 4, 6, 8kHz; bone conduction at 0.5, 1, 2, 3, 4 kHz) with calculation of air bone gap at 0.5, 1, 2, 3 and 4kHz. Assessed pre-intervention and post-intervention at 2 weeks and 6 months	Assessed pre-intervention and post-intervention at 2 weeks and 6 months.

Collaborators and Investigators

• Sponsor: University Hospital Plymouth NHS Trust
• Investigators: Principal Investigator: James Rainsbury, BMBS MSc FRCS, University Hospital Plymouth NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2016
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (ESTIMATE): December 16, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Grade 2 retraction of the pars tensa of the tympanic membrane; Grade 3 retraction of the pars tensa of the tympanic membrane
• Other Study ID Numbers: 15/P/164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED