NCT03556215|Completed
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Ministry of Health of the Czech Republic
interventional
55
1 country
2
Study Start
May 1, 2016
Actual (reported)Primary Completion
May 31, 2020
Actual (reported)Study Completion
November 30, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2016
Actual (reported)May 20, 2018
Actual (reported)June 14, 2018
Actual (reported)May 31, 2020
Actual (reported)November 30, 2020
Actual (reported)Otomicro(endo)scopy
Otomicro(endo)scopy will be used to assess the presence or absence of effusion.
36 months
Symptoms severity according to Visual Analogue Scale
36 months
ETDQ-7 questionnaire
36 months
Tympanometry
Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty, and myringotomy
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)
Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.
University Hospital Hradec Králové
Hradec Králové, Hradec Králové Region, 500 05, Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52, Czechia
Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.
Pavel Komínek, prof.,MD,Ph.D.,MBA
University Hospital Ostrava
Martin Formánek, MD
University Hospital Ostrava
55 participants (actual enrollment reported by the registry).
First Submitted
May 20, 2018
First Posted
June 14, 2018
Study Start
May 1, 2016
Actual (reported)36 months
Audiometry
36 months
Tubomanometry
36 months
Patients with chronic Eustachian tube dysfunction and airy middle ear (without otitis media with effusion), Eustachian tube dilatation device, no myringotomy
Myringotomy will be performed using a standard procedure.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 31, 2020
Actual (reported)Study Completion
November 30, 2020
Actual (reported)Last Updated
December 7, 2022
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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