Eustachian Tube Dilation With an Endovascular Balloon

NCT ID: NCT04809753

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2022-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Eustachian tube dilation

Eustachian tube dilation with an endovascular balloon

Group Type: EXPERIMENTAL

Eustachian tube dilation

Intervention Type: DEVICE

Dilation of the eustachian tube with an endovascular balloon

Interventions

Eustachian tube dilation

Dilation of the eustachian tube with an endovascular balloon

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trung Le, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center

Locations

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36855202 (View on PubMed)

Other Identifiers

3776

Identifier Type: -

Identifier Source: org_study_id