Feasibility Study of Balloon Eustachian Tuboplasty (BET)

Eustachian Tube Dysfunction Clinical Trial

— BET  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02631187
• Other study ID #: 15/P/164
• Status: Withdrawn
• Phase: N/A
• First received: December 1, 2015
• Last updated: November 15, 2017
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: October 2016
• Source: Plymouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eustachian Tube Dysfunction
• Retraction of the Pars Tensa of the Tympanic Membrane
• Retraction Pocket of the Tympanic Membrane

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
Plymouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Demand	Demand assessed by recruitment rate	1 year
Secondary	Cost analysis of treatment	Cost analysis of BET vs. cartilage tympanoplasty	1 year
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.