Eustachian Tube Dilation With an Endovascular Balloon

NCT04809753 | Completed

• 1 other identifier: 3776
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Eustachian Tube Dysfunction; Eustachian Tube Dysfunction of Both Ears

Outcome Measures

Primary Outcomes (1)

• Succesfull procedure

  o Feasibility to perform the procedure after ear surgery with no local complication and within 15-20 minutes

  20 minutes

Secondary Outcomes (3)

• CT

  5 minutes

• ETDQ - 7 (Eustachian Tube Dysfunction Questionnaire - Item 7)

  2 minutes

• Endoscopic evaluation

  5 minutes

Study Arms (1)

Eustachian tube dilation

EXPERIMENTAL

Eustachian tube dilation with an endovascular balloon

Device: Eustachian tube dilation

Interventions

Eustachian tube dilation DEVICE

Dilation of the eustachian tube with an endovascular balloon

Eustachian tube dilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Dahm V, Lui JT, Jung S, Lin VY, Chen JM, Le TN. The feasibility and safety of eustachian tube dilation with a standard endovascular balloon: a clinical pilot study. J Otolaryngol Head Neck Surg. 2023 Feb 28;52(1):20. doi: 10.1186/s40463-022-00599-1.

  PMID: 36855202 DERIVED

Study Officials

• Trung Le, MD

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 22, 2021
• Study Start: March 29, 2021
• Primary Completion: August 20, 2021
• Study Completion: February 28, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)