Eustachian Tube Dilation With an Endovascular Balloon

Eustachian Tube Dysfunction Clinical Trial

Official title:

Eustachian Tube Dilation Using an Angioplasty Balloon - a Pilot Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809753
• Other study ID #: 3776
• Status: Completed
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: October 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 28, 2022
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eustachian Tube Dysfunction
• Eustachian Tube Dysfunction of Both Ears

Intervention

Device:
• Eustachian tube dilation
Dilation of the eustachian tube with an endovascular balloon

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Succesfull procedure	o Feasibility to perform the procedure after ear surgery with no local complication and within 15-20 minutes	20 minutes
Secondary	CT	o Safety evaluated after the procedure CT scan. Complications (adverse and serious adverse events related to the device or procedure)	5 minutes
Secondary	ETDQ - 7 (Eustachian Tube Dysfunction Questionnaire - Item 7)	o Mean change in overall ETDQ-7 scores from baseline at 2- and 6-months follow-up	2 minutes
Secondary	Endoscopic evaluation	Safety evaluated after the procedure by endoscopic examination and CT scan. Complications (adverse and serious adverse events related to the device or procedure)	5 minutes