Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2022-02-24
2023-08-28
Brief Summary
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1. balloon dilation of the eustachian tube or
2. nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months
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Detailed Description
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They will be randomized to one of two groups
group 1 - surgical dilation of the eustachian tube in general anaesthesia
group 2 - daily nasal saline spray, twice a day
Regular Follow up with Tympanogram and Questionnaire
After three months patient in the control group (nasal saline) can switch in the intervention group.
Eustachian tube dilation will be carried out with a Health Canada and FDA approved device, usually used for endovascular balloon dilation. It has the same size and pressure properties as the eustachian tube dilation device and has shown a good safety profile in a previous preclinical and clinical pilot study.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Eustachian tube dilation
Surgical Eustachian tube dilation in general anaesthesia
Balloon dilation of the eustachian tube
Balloon dilation of the eustachian tube
Control Group
nasal saline spray
No interventions assigned to this group
Interventions
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Balloon dilation of the eustachian tube
Balloon dilation of the eustachian tube
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with persistent obstructive eustachian tube dysfunction (OETD) for at least 3 months prior to enrolment uni- and/or bilateral
Diagnosis (both required):
i. Persistent OETD symptoms assessed by Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with overall score of ≥3 (moderate to severe symptoms) for 3 months or more prior to enrollment.
ii. Refractory to medical therapy (minimum of 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 3 months before study enrollment).
Exclusion Criteria
* Prior eustachian tube intervention
* Presence of myringotomy ventilation tube or a tympanic membrane perforation
* Active chronic or acute otitis media
* Chronic otitis media with cholesteatoma
* Fluctuating sensorineural hearing loss or Meniere's disease
* Chronic rhinosinusitis, allergies, or reflux disease not controlled with medication
* History of head or neck surgery within 3 months
* Prior radiation to the head and neck
* Active temporomandibular joint disorders
* Cleft palate or Craniofacial syndrome
* Cystic fibrosis or Ciliary dysmotility syndrome or Systemic immunodeficiencies
* Active acute upper respiratory infection
* Nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the Eustachian tube
* CT temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression
* Patient unable to follow protocol for any reason
18 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Trung N Le, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Center
Locations
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Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Countries
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References
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Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.
Other Identifiers
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3156
Identifier Type: -
Identifier Source: org_study_id
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