Glue EarNCT03499015
Balloon Dilation of the Eustachian Tube in Children
A study testing Balloon Eustachian Tuboplasty (BET) in people with Glue Ear and Tube Disorders Eustachian, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Glue Ear, Tube Disorders Eustachian
- What is being tested?
- Balloon Eustachian Tuboplasty (BET)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 14 Dec 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- OME on both sides measured by flat tympanometry
Who cannot join
- Patients with cleft lip and/or palate and other severe craniofacial abnormalities
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical university of Vienna
Vienna, 1090
Gerold Besser, gerold.besser@meduniwien.ac.at
About this study
Official title: 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.
Read the 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.
- Conditions
- Glue Ear, Tube Disorders Eustachian
- Being tested
- Balloon Eustachian Tuboplasty (BET)
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Eustachian Tuboplasty (BET)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ear without BET | No intervention | ear without BET treatment works as control |
| BET ear | Experimental | ear with BET treatment works as intervention arm Receives: Procedure: Balloon Eustachian Tuboplasty (BET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;
Secondary outcomes (1)
Otoscopy score
0= no effusion (Valsalva +/-, not feasible)
- retracted eardrum
- Fluid or bubbles through eardrum visible
- complete fluid blockage of middle ear
Measured: up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start14 Dec 2018 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Glue EarStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-sided treatment, contralateral side with same pathology works as control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Arnoldner, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499015
- Sponsor's protocol ID
- EK Nr: 1795/2017
- Status last verified
- Nov 2018
- First submitted
- 25 Mar 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26833645Maier 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.
PubMed 26311130Tisch 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.
PubMed 23712367Popova 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.
PubMed 20399511Jenckel 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.
PubMed 25524643Van 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.
PubMed 28265561Poe 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.
PubMed 28940574
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Dilation of the Eustachian Tube in Children: a Randomized Side-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03499015
- Acronym / sponsor ID
- EK Nr: 1795/2017
- Conditions
- Glue Ear, Tube Disorders Eustachian
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 14 Dec 2018 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- single-sided treatment, contralateral side with same pathology works as control
| Arm | Type | Receives |
|---|---|---|
| Ear without BET | No intervention | –ear without BET treatment works as control |
| BET ear | Experimental | Procedure: Balloon Eustachian Tuboplasty (BET)ear with BET treatment works as intervention arm |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- OME on both sides measured by flat tympanometry
Key exclusion criteria (1 listed)
- Patients with cleft lip and/or palate and other severe craniofacial abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | BET ear |
Primary outcome
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.
1 secondary outcome
Otoscopy score
Time frame: up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Background: PubMed 26833645Rosenfeld 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.
- Background: PubMed 26311130Maier 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.
- Background: PubMed 23712367Tisch 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.
- Background: PubMed 20399511Popova 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.
- Background: PubMed 25524643Jenckel 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.
- Background: PubMed 28265561Van 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.
- Background: PubMed 28940574Poe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Eustachian Tuboplasty (BET) in people with Glue Ear and Tube Disorders Eustachian, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerold Besser, M.D. (004314040033300, gerold.besser@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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;). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499015, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.