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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• ≥18 years old (of both sexes)

• Diagnosed with persistent obstructive eustachian tube dysfunction (OETD) for at least 3 months prior to enrolment uni- and/or bilateral

• Diagnosis (both required):

• i. Persistent OETD symptoms assessed by Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with overall score of ≥3 (moderate to severe symptoms) for 3 months or more prior to enrollment.

• ii. Refractory to medical therapy (minimum of 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 3 months before study enrollment).

Locations
Other Locations
Canada
Sunnybrook Health Sciences Center
Recruiting
Toronto
Contact Information
Primary
Kaye Dizon
kaye.dizon@sunnybrook.ca
416 480 6100
Time Frame
Start Date: February 24, 2022
Estimated Completion Date: February 28, 2026
Participants
Target number of participants: 58
Treatments
Experimental: Eustachian tube dilation
Surgical Eustachian tube dilation in general anaesthesia
No Intervention: Control Group
nasal saline spray
Authors
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov

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