Balloon Dilation of the Eustachian Tube in Children

November 11, 2018 updated by: Christoph Arnoldner, Medical University of Vienna

Balloon Dilation of the Eustachian Tube in Children: a Randomized Side-controlled Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Otitis media with effusion (OME, "glue ear") is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Fluid in the middle ear causes conducting hearing loss. OME has a large impact on health care costs and recurrent or persistent OME can effect the proper development of children. Frequently OME resolves itself, therefore guidelines strongly recommend watchful waiting for 3 months after which treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures. Furthermore there are various short and longterm side-effects of tympanostomy tubes.In Balloon Eustachian Tuboplasty (BET) a ballon 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. BET has recently been applied in children for therapy-resistant recurrent OME and inflammatory ear diseases with promising results. Risk and complications rates are very low.

Methods:

Goal of this study will be the evaluation of Balloon Eustachian Tuboplasty (BET) in children as a primary treatment of OME. Children between the ages of 4 and 10 years with OME and tympanometry type B on both ears, will prospectively be recruited and assigned for adenoidectomy and myringotomy. Parents then will be asked for participation in this trial and fully informed about purpose, technique and possible side effects. If consent is given, adenoidectomy, in case of large adenoids, and myringotomy will be performed on both sides. If necessary (very thick fluid) tympanostomy tubes are placed. One Eustachian tube of each patient is randomly assigned for BET.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OME on both sides measured by flat tympanometry

Exclusion Criteria:

  • Patients with cleft lip and/or palate and other severe craniofacial abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Ear without BET
ear without BET treatment works as control
Experimental: BET ear
ear with BET treatment works as intervention arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tympanometry-Change (Middle ear effusion/eardrum mobility assessed with Tympanometry)
Time Frame: up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;
Tympanometry, an objective test of middle-ear function, uses variations of air pressure in the ear canal to assess for middle ear effusion / eardrum mobility.
up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Otoscopy score
Time Frame: up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;

0= no effusion (Valsalva +/-, not feasible)

  1. retracted eardrum
  2. Fluid or bubbles through eardrum visible
  3. complete fluid blockage of middle ear
up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptom-based side depended questionnaire
Time Frame: preoperatively and 9 months postoperatively
subjective scale side depended (zero to ten points - low to high disturbance by symptom). Symptoms asked for e.g. ear-fullness, pressure, pain, etc.
preoperatively and 9 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 14, 2018

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

March 25, 2018

First Submitted That Met QC Criteria

April 13, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 11, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK Nr: 1795/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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