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Balloon Dilation of the Eustachian Tube in Children

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ClinicalTrials.gov Identifier: NCT03499015
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Christoph Arnoldner, Medical University of Vienna

Brief 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.


Condition or disease Intervention/treatment Phase
Glue Ear Tube Disorders Eustachian Procedure: Balloon Eustachian Tuboplasty (BET) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-sided treatment, contralateral side with same pathology works as control
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: only surgeon knows treated side, documentation of side only visible to surgeon and investigator
Primary Purpose: Treatment
Official Title: Balloon Dilation of the Eustachian Tube in Children: a Randomized Side-controlled Clinical Trial
Estimated Study Start Date : December 14, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : October 1, 2020

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OME on both sides measured by flat tympanometry

Exclusion Criteria:

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

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): NCT03499015


Contacts
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Contact: Gerold Besser, M.D. 004314040033300 gerold.besser@meduniwien.ac.at
Contact: Valerie Dahm, M.D. 004314040033300 valerie.dahm@meduniwien.ac.at

Locations
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Austria
Medical university of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerold Besser       gerold.besser@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna

Publications:

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Responsible Party: Christoph Arnoldner, Assoc. Prof. PD M.D., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03499015    
Other Study ID Numbers: EK Nr: 1795/2017
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical