Clinical trial NCT05270031: Balloon Dilation of the Eustachian Tube
Official title: A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eustachian Tube Dysfunction
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross Over after 3 months possible
Primary purpose: TREATMENT

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 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Otoscopy, Normal, Retracted or Middle ear effusion
timeFrame: 6 weeks
measure: Otoscopy, Normal, Retracted or Middle ear effusion
timeFrame: 3 motnths
measure: Otoscopy, Normal, Retracted or Middle ear effusion
timeFrame: 6 months
measure: Otoscopy, Normal, Retracted or Middle ear effusion
timeFrame: 12 months
Secondary outcomes:
measure: Valsalva maneuver -positive or negative
timeFrame: 6 weeks
measure: Valsalva maneuver -positive or negative
timeFrame: 3 months
measure: Valsalva maneuver -positive or negative
timeFrame: 6 months
measure: Valsalva maneuver -positive or negative
timeFrame: 12 months
measure: Tympanogram
timeFrame: 3 months
measure: Tympanogram
timeFrame: 6 months
measure: Tympanogram
timeFrame: 12 months
measure: ETDQ-7 (eustachian tube dilation questionnaire - seven)
timeFrame: 6 weeks
measure: ETDQ-7 (eustachian tube dilation questionnaire - seven)
timeFrame: 3 months
measure: ETDQ-7 (eustachian tube dilation questionnaire - seven)
timeFrame: 6 months
measure: ETDQ-7 (eustachian tube dilation questionnaire - seven)
timeFrame: 12 months
measure: HUI (Health utility index)
timeFrame: 6 weeks
measure: HUI (Health utility index)
timeFrame: 3 months
measure: HUI (Health utility index)
timeFrame: 6 months
measure: HUI (Health utility index)
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Center
name: Trung N Le, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: