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Balloon Dilation of the Eustachian Tube in Children

NCT03499015 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-11-14

No results posted yet for this study

Summary

Otitis media with effusion (OME) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures.

Goal of this study will be to evaluate the Balloon Eustachian Tuboplasty (BET) in children as an additional treatment option and to assess long-term effects of BET. Beside the standard procedure, children (4 to 10 years of age), with equal pathology on both ears, will be assigned for BET on side.

Conditions

  • Glue Ear
  • Tube Disorders Eustachian

Interventions

PROCEDURE

Balloon Eustachian Tuboplasty (BET)

A balloon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-14
Primary Completion
2020-03-01
Completion
2020-10-01

Countries

  • Austria

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 NCT03499015 on ClinicalTrials.gov