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Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

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ClinicalTrials.gov Identifier: NCT03556215
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
University Hospital Hradec Kralove
Information provided by (Responsible Party):
University Hospital Ostrava

Tracking Information
First Submitted Date  ICMJE May 20, 2018
First Posted Date  ICMJE June 14, 2018
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE May 1, 2016
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
Otomicro(endo)scopy [ Time Frame: 36 months ]
Otomicro(endo)scopy will be used to assess the presence or absence of effusion.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03556215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
  • Symptoms severity according to Visual Analogue Scale [ Time Frame: 36 months ]
    Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
  • ETDQ-7 questionnaire [ Time Frame: 36 months ]
    The patients will be asked to fill-in the Eustachian Tube Dysfunction Questionnaire in order to assess the symptoms of Eustachian Tube Dysfunction (ETD). The ETDQ-7 is a valid and reliable symptom score for use in adult patients with ETD. The ETDQ-7 tool consists of seven items with a scale of graduated responses ranging from 1 to 7, with "1" corresponding to the absence of the suggested symptom and "7", to maximum symptom severity.
  • Tympanometry [ Time Frame: 36 months ]
    Type of tympanometry curve (A, B, C) according to Joerger et al.
  • Audiometry [ Time Frame: 36 months ]
    Hearing loss according to WHO classification (mild, moderate, severe).
  • Tubomanometry [ Time Frame: 36 months ]
    Assessment of opening pressure in Eustachian tube in mmHg.
  • Possibility of Valsalva and Toynbee manoeuvre [ Time Frame: 36 months ]
    The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
  • Symptoms severity according to VAS [ Time Frame: 36 months ]
    Symptoms severity will be assessed on Visual Analogue Scale (values 1-10).
  • ETDQ-7 questionnaire [ Time Frame: 36 months ]
    The patients will be asked to fill-in the Eustachian Tube Dysfunction Questionnaire in order to assess the symptoms
  • Tympanometry [ Time Frame: 36 months ]
    Type of tympanometry curve (A, B, C) according to Joerger et al.
  • Audiometry [ Time Frame: 36 months ]
    Hearing loss according to WHO classification (mild, moderate, severe).
  • Tubomanometry [ Time Frame: 36 months ]
    Assessment of opening pressure in Eustachian tube in mmHg.
  • Possibility of Valsalva and Toynbee manoeuvre [ Time Frame: 36 months ]
    The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
Official Title  ICMJE Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
Brief Summary

The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group.

Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. Subgroups will be compared in order to identify treatment effect in particular subgroups.

Detailed Description

The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group.

Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. The otomicro(endo)scopy, symptoms severity according to VAS (Visual Analogue Pain Scale), ETDQ-7 (Eustachian Tube Dysfunction Questionnaire) questionnaire, tympanometry, audiometry and the possibility of Valsalva and Toynbee maneuver will be used to evaluate the effect of balloon ET dilatation. Only patients with standard treatment failure will be included in the study. Tuboplasty with and without myringotomy will be performed (and compared) in patients with chronic otitis media with effusion. Subgroups will be compared in order to find patients who could profit from the treatments the most.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Interventional parallel randomized controlled prospective trial
Masking: None (Open Label)
Masking Description:
No masking was used in the study
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Eustachian Tube Dysfunction
  • Chronic Recurrent Otitis Media
  • Effusion After Tympanostomy
Intervention  ICMJE
  • Device: Eustachian tube dilatation device
    Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.
  • Procedure: Myringotomy
    Myringotomy will be performed using a standard procedure.
Study Arms  ICMJE
  • Experimental: Effusion, Eustachian tube dilatation device and myringotomy
    Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty, and myringotomy
    Interventions:
    • Device: Eustachian tube dilatation device
    • Procedure: Myringotomy
  • Experimental: Effusion, Eustachian tube dilatation device
    Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty only (no myringotomy)
    Intervention: Device: Eustachian tube dilatation device
  • Experimental: No effusion, Eustachian tube dilatation device
    Patients with chronic Eustachian tube dysfunction and airy middle ear (without otitis media with effusion), Eustachian tube dilatation device, no myringotomy
    Intervention: Device: Eustachian tube dilatation device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2018)
55
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients with chronic Eustachian tube dysfunction lasting more than 6 months, with or without recurrence of chronic otitis media with effusion after tympanostomy

Exclusion Criteria:

  • anatomic obstruction in nasopharynx
  • nasopharyngeal cancer
  • head and neck cancer
  • other middle ear surgery except for myringotomy or tympanostomy
  • chronic suppurative otitis media
  • patients who could not undergo general anesthesia
  • patients who did not give consent to be included in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Petr Vávra, Ass.Prof.,MD,Ph.D. 0042059737 ext 2544 petr.vavra@fno.cz
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03556215
Other Study ID Numbers  ICMJE FNO-ENT-BET
MH CZ - DRO - FNOs/2016 ( Other Grant/Funding Number: Ministry of Health of the Czech Republic )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The investigators have not decided to make individual participant data available to other researchers.
Responsible Party University Hospital Ostrava
Study Sponsor  ICMJE University Hospital Ostrava
Collaborators  ICMJE University Hospital Hradec Kralove
Investigators  ICMJE
Study Chair: Pavel Komínek, prof.,MD,Ph.D.,MBA University Hospital Ostrava
Principal Investigator: Martin Formánek, MD University Hospital Ostrava
PRS Account University Hospital Ostrava
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP