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Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

NCT03556215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-12-07

No results posted yet for this study

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.

Conditions

  • Chronic Eustachian Tube Dysfunction
  • Chronic Recurrent Otitis Media
  • Effusion After Tympanostomy

Interventions

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.

Sponsors & Collaborators

  • University Hospital Hradec Kralove

    collaborator OTHER

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Pavel Komínek, prof.,MD,Ph.D.,MBA · University Hospital Ostrava

  • Martin Formánek, MD · University Hospital Ostrava

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2020-05-31
Completion
2020-11-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03556215 on ClinicalTrials.gov