NCT05270031TerminatedNot Applicable
A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon
Sunnybrook Health Sciences Centre1 site in 1 country15 target enrollmentStarted: February 24, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Otoscopy, Normal, Retracted or Middle ear effusion
Study Overview
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.
- balloon dilation of the eustachian tube or
- nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months
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 anaesthesia
group 2 - daily nasal saline spray, twice a day
Regular Follow up with Tympanogram and Questionnaire
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 extrinsic eustachian tube compression
- •Patient unable to follow protocol for any reason
Arms & Interventions
Eustachian tube dilation
Experimental
Surgical Eustachian tube dilation in general anaesthesia
Intervention: Balloon dilation of the eustachian tube (Device)
Control Group
No Intervention
nasal saline spray
Outcomes
Primary Outcomes
Otoscopy, Normal, Retracted or Middle ear effusion
Time Frame: 12 months
Microscopic evaluation of tympanic membrane
Otoscopy, Normal, Retracted or Middle ear effusion
Time Frame: 6 weeks
Microscopic evaluation of tympanic membrane
Otoscopy, Normal, Retracted or Middle ear effusion
Time Frame: 3 motnths
Microscopic evaluation of tympanic membrane
Otoscopy, Normal, Retracted or Middle ear effusion
Time Frame: 6 months
Microscopic evaluation of tympanic membrane
Secondary Outcomes
- Tympanogram(12 months)
- Valsalva maneuver -positive or negative(12 months)
- HUI (Health utility index)(12 months)
- ETDQ-7 (eustachian tube dilation questionnaire - seven)(12 months)
- HUI (Health utility index)(3 months)
- Tympanogram(6 months)
- Valsalva maneuver -positive or negative(6 weeks)
- Valsalva maneuver -positive or negative(3 months)
- Valsalva maneuver -positive or negative(6 months)
- Tympanogram(3 months)
- ETDQ-7 (eustachian tube dilation questionnaire - seven)(6 weeks)
- ETDQ-7 (eustachian tube dilation questionnaire - seven)(3 months)
- ETDQ-7 (eustachian tube dilation questionnaire - seven)(6 months)
- HUI (Health utility index)(6 weeks)
- HUI (Health utility index)(6 months)
Investigators
Study Sites (1)
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