Balloon Dilation of the Eustachian Tube in Children
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedStudy Start
First participant enrolled
December 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedNovember 14, 2018
November 1, 2018
1.2 years
March 25, 2018
November 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Tympanometry-Change (Middle ear effusion/eardrum mobility assessed with Tympanometry)
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 Outcomes (1)
Otoscopy score
up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;
Other Outcomes (1)
symptom-based side depended questionnaire
preoperatively and 9 months postoperatively
Study Arms (2)
Ear without BET
NO INTERVENTIONear without BET treatment works as control
BET ear
EXPERIMENTALear with BET treatment works as intervention arm
Interventions
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.
Eligibility Criteria
You may qualify if:
- OME on both sides measured by flat tympanometry
You may not qualify if:
- Patients with cleft lip and/or palate and other severe craniofacial abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical university of Vienna
Vienna, 1090, Austria
Related Publications (7)
Rosenfeld RM, Shin JJ, Schwartz SR, Coggins R, Gagnon L, Hackell JM, Hoelting D, Hunter LL, Kummer AW, Payne SC, Poe DS, Veling M, Vila PM, Walsh SA, Corrigan MD. Clinical Practice Guideline: Otitis Media with Effusion Executive Summary (Update). Otolaryngol Head Neck Surg. 2016 Feb;154(2):201-14. doi: 10.1177/0194599815624407.
PMID: 26833645BACKGROUNDMaier S, Tisch M, Maier H. [Balloon dilation of the Eustachian tube in pediatric chronic obstructive Eustachian tube dysfunction patients]. HNO. 2015 Oct;63(10):686-8, 690-4, 696-7. doi: 10.1007/s00106-015-0050-5. German.
PMID: 26311130BACKGROUNDTisch M, Maier S, Hecht P, Maier H. [Bilateral Eustachian tube dilation in infants: an alternative treatment for persistent middle ear functional dysfunction]. HNO. 2013 Jun;61(6):492-3. doi: 10.1007/s00106-013-2713-4. German.
PMID: 23712367BACKGROUNDPopova D, Varbanova S, Popov TM. Comparison between myringotomy and tympanostomy tubes in combination with adenoidectomy in 3-7-year-old children with otitis media with effusion. Int J Pediatr Otorhinolaryngol. 2010 Jul;74(7):777-80. doi: 10.1016/j.ijporl.2010.03.054.
PMID: 20399511BACKGROUNDJenckel F, Kappo N, Gliese A, Loewenthal M, Lorincz BB, Knecht R, Dalchow CV. Endonasal dilatation of the Eustachian tube (EET) in children: feasibility and the role of tubomanometry (Esteve) in outcomes measurement. Eur Arch Otorhinolaryngol. 2015 Dec;272(12):3677-83. doi: 10.1007/s00405-014-3443-2. Epub 2014 Dec 19.
PMID: 25524643BACKGROUNDVan Roeyen S, Van de Heyning P, Van Rompaey V. Delayed-Start Study Design for Balloon Dilation of the Eustachian Tube: Alternative for a Randomized Controlled Trial. Front Surg. 2017 Feb 20;4:10. doi: 10.3389/fsurg.2017.00010. eCollection 2017. No abstract available.
PMID: 28265561BACKGROUNDPoe D, Anand V, Dean M, Roberts WH, Stolovitzky JP, Hoffmann K, Nachlas NE, Light JP, Widick MH, Sugrue JP, Elliott CL, Rosenberg SI, Guillory P, Brown N, Syms CA 3rd, Hilton CW, McElveen JT Jr, Singh A, Weiss RL Jr, Arriaga MA, Leopold JP. Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. 2018 May;128(5):1200-1206. doi: 10.1002/lary.26827. Epub 2017 Sep 20.
PMID: 28940574BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- only surgeon knows treated side, documentation of side only visible to surgeon and investigator
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. PD M.D.
Study Record Dates
First Submitted
March 25, 2018
First Posted
April 17, 2018
Study Start
December 14, 2018
Primary Completion
March 1, 2020
Study Completion
October 1, 2020
Last Updated
November 14, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share