Balloon Dilation of the Eustachian Tube (NCT05270031) | Clinical Trial Compass
TerminatedNot Applicable
Balloon Dilation of the Eustachian Tube
Stopped: lack of funding
Canada15 participantsStarted 2022-02-24
Plain-language summary
In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups.
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥18 years old (of both sexes)
* 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:
* Patulous eustachian tube
* 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 ext…
What they're measuring
1
Otoscopy, Normal, Retracted or Middle ear effusion
Timeframe: 6 weeks
2
Otoscopy, Normal, Retracted or Middle ear effusion
Timeframe: 3 motnths
3
Otoscopy, Normal, Retracted or Middle ear effusion
Timeframe: 6 months
4
Otoscopy, Normal, Retracted or Middle ear effusion