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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

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.


Condition or disease Intervention/treatment Phase
Chronic Eustachian Tube Dysfunction Chronic Recurrent Otitis Media Effusion After Tympanostomy Device: Eustachian tube dilatation device Procedure: Myringotomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
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
Official Title: Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

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)
Device: Eustachian tube dilatation device
Balloon Eustachian tuboplasty will be performed using a 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
Device: Eustachian tube dilatation device
Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.




Primary Outcome Measures :
  1. Otomicro(endo)scopy [ Time Frame: 36 months ]
    Otomicro(endo)scopy will be used to assess the presence or absence of effusion.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Tympanometry [ Time Frame: 36 months ]
    Type of tympanometry curve (A, B, C) according to Joerger et al.

  4. Audiometry [ Time Frame: 36 months ]
    Hearing loss according to WHO classification (mild, moderate, severe).

  5. Tubomanometry [ Time Frame: 36 months ]
    Assessment of opening pressure in Eustachian tube in mmHg.

  6. Possibility of Valsalva and Toynbee manoeuvre [ Time Frame: 36 months ]
    The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556215


Contacts
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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

Locations
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Czechia
University Hospital Hradec Králové Recruiting
Hradec Králové, Hradec Králové Region, Czechia, 500 05
Principal Investigator: Lukáš Školoudík, MD,Ph.D.         
University Hospital Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 708 52
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   
Principal Investigator: Martin Formánek, MD         
Sub-Investigator: Pavel Komínek, prof.,MD,Ph.D.,MBA         
Sub-Investigator: Debora Jančatová, MD         
Sub-Investigator: Karol Zeleník, MD,Ph.D.         
Sponsors and Collaborators
University Hospital Ostrava
University Hospital Hradec Kralove
Investigators
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Study Chair: Pavel Komínek, prof.,MD,Ph.D.,MBA University Hospital Ostrava
Principal Investigator: Martin Formánek, MD University Hospital Ostrava

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03556215     History of Changes
Other Study ID Numbers: FNO-ENT-BET
MH CZ - DRO - FNOs/2016 ( Other Grant/Funding Number: Ministry of Health of the Czech Republic )
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators have not decided to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Ostrava:
otitis media with effusion
balloon tuboplasty
Eustachian tube
Eustachian tube dysfunction
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases