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Eustachian Tube Dilation With an Endovascular Balloon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04809753
Recruitment Status : Completed
First Posted : March 22, 2021
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eustachian Tube Dysfunction Eustachian Tube Dysfunction of Both Ears Device: Eustachian tube dilation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Eustachian Tube Dilation Using an Angioplasty Balloon - a Pilot Safety Study
Actual Study Start Date : March 29, 2021
Actual Primary Completion Date : August 20, 2021
Actual Study Completion Date : February 28, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Eustachian tube dilation
Eustachian tube dilation with an endovascular balloon
 Device: Eustachian tube dilation
Dilation of the eustachian tube with an endovascular balloon


Outcome Measures
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Primary Outcome Measures :
  1. Succesfull procedure [ Time Frame: 20 minutes ]
    o Feasibility to perform the procedure after ear surgery with no local complication and within 15-20 minutes


Secondary Outcome Measures :
  1. CT [ Time Frame: 5 minutes ]
    o Safety evaluated after the procedure CT scan. Complications (adverse and serious adverse events related to the device or procedure)

  2. ETDQ - 7 (Eustachian Tube Dysfunction Questionnaire - Item 7) [ Time Frame: 2 minutes ]
    o Mean change in overall ETDQ-7 scores from baseline at 2- and 6-months follow-up

  3. Endoscopic evaluation [ Time Frame: 5 minutes ]
    Safety evaluated after the procedure by endoscopic examination and CT scan. Complications (adverse and serious adverse events related to the device or procedure)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04809753


Locations
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Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Trung Le, MD Sunnybrook Health Sciences Center
More Information
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04809753    
Other Study ID Numbers: 3776
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (consent form (anonymized), study protocol) will be shared upon reasonable request after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical