Eustachian Tube Dilation With an Endovascular Balloon

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

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.

Study Overview

• Status: Completed
• Conditions: Eustachian Tube Dysfunction; Eustachian Tube Dysfunction of Both Ears
• Intervention / Treatment: Device: Eustachian tube dilation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Succesfull procedure	o Feasibility to perform the procedure after ear surgery with no local complication and within 15-20 minutes	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT	o Safety evaluated after the procedure CT scan. Complications (adverse and serious adverse events related to the device or procedure)	5 minutes
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
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Trung Le, MD, Sunnybrook Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): August 20, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: 3776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data (consent form (anonymized), study protocol) will be shared upon reasonable request after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No