NCT05270031

Balloon Dilation of the Eustachian Tube

A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups. 1. balloon dilation of the eustachian tube or 2. nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months

Detailed description

Patients will eustachian tube dysfunction will be asked to participate in the study. They will be randomized to one of two groups group 1 - surgical dilation of the eustachian tube in general anaesthesia group 2 - daily nasal saline spray, twice a day Regular Follow up with Tympanogram and Questionnaire After three months patient in the control group (nasal saline) can switch in the intervention group. Eustachian tube dilation will be carried out with a Health Canada and FDA approved device, usually used for endovascular balloon dilation. It has the same size and pressure properties as the eustachian tube dilation device and has shown a good safety profile in a previous preclinical and clinical pilot study.

Conditions

• Eustachian Tube Dysfunction

Interventions

Type	Name	Description
DEVICE	Balloon dilation of the eustachian tube	Balloon dilation of the eustachian tube

Timeline

• Start date: 2022-02-24
• Primary completion: 2023-05-28
• Completion: 2023-08-28
• First posted: 2022-03-08
• Last updated: 2023-09-08

Locations

1 site across 1 country: Canada