Status:
TERMINATED
Balloon Dilation of the Eustachian Tube
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Eustachian Tube Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Patients will eustachian tube dysfunction will be asked to participate in the study. They will be randomized to one of two groups group 1 - surgical dilation of the eustachian tube in general anaest...
Eligibility Criteria
Inclusion
- ≥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
- 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 extrinsic eustachian tube compression
- Patient unable to follow protocol for any reason
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05270031
Start Date
February 24 2022
End Date
August 28 2023
Last Update
September 8 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada