Clinical trial NCT04809753: Eustachian Tube Dilation With an Endovascular Balloon
Official title: Eustachian Tube Dilation Using an Angioplasty Balloon - a Pilot Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eustachian Tube Dysfunction
Eustachian Tube Dysfunction of Both Ears
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The Eustachian tube is a narrow tube which links the back of the nose to the middle ear. Eustachian tube dysfunction may occur when the mucosal lining of the tube is swollen, or does not open or close properly. It can occur after the start of a cold and other nose, sinus, ear and throat infections causing ear pain and pressure, fullness, cracking/popping sounds. This is an ubiquitous healthcare problem, affecting children and adults, that can lead to severe consequences including hearing loss, chronic otitis media, tinnitus, and vertigo. Numerous studies have consistently failed to support the effectiveness of medical managements. Pressure equalizing tubes are considered a temporary solution that does not treat the underlying pathology. More recent preliminary evidence of using inflation of a noncompressible balloon in the eustachian tube improved clinical outcomes, patients' symptoms and quality of life. This eustachian dilation catheter is not accessible in Canada since the device and procedure is not covered by OHIP (Ontario health insurance plan) or any other health insurance in Canada. In a cadaver study, we have evaluated using an endovascular balloon (Balloon that is used to dilate (expand) vessels) for eustachian tube dilation, which only costs about 10% of the eustachian tube dilation device. This endovascular balloon is Health Canada approved, but not for this specific use. We therefore want to conduct a pilot safety study with the main goal of assessing feasibility of eustachian tube dilation with the endovascular device.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old (of both sexes)
* Diagnosed with unilateral or bilateral persistent obstructive eustachian tube dysfunction (OETD)
* Undergoing tympanoplasty or tympanomastoidectomy

Exclusion Criteria:

* Patulous eustachian tube
* Preoperative 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
* Cleft palate or Craniofacial syndrome
* Prior eustachian tube intervention
* Prior radiation to the head and neck

Primary outcomes:
measure: Succesfull procedure
timeFrame: 20 minutes
Secondary outcomes:
measure: CT
timeFrame: 5 minutes
measure: ETDQ - 7 (Eustachian Tube Dysfunction Questionnaire - Item 7)
timeFrame: 2 minutes
measure: Endoscopic evaluation
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Center
name: Trung Le, MD
role: PRINCIPAL_INVESTIGATOR
References: