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Balloon dilation of the eustachian tube for Eustachian Tube Dysfunction (BDET Trial)
N/A
Waitlist Available
Led By Trung N Le, MD, PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial involves patients with eustachian tube dysfunction. One group will receive a balloon treatment to open their ear tubes, while the other will use a saltwater nasal spray. The balloon helps open the tube directly, and the spray keeps nasal passages clear. Balloon dilation of the Eustachian tube is a promising treatment for chronic Eustachian tube dysfunction, showing positive outcomes in various studies.
Eligible Conditions
- Eustachian Tube Dysfunction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Otoscopy, Normal, Retracted or Middle ear effusion
Secondary study objectives
ETDQ-7 (eustachian tube dilation questionnaire - seven)
HUI (Health utility index)
Tympanogram
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Eustachian tube dilationExperimental Treatment1 Intervention
Surgical Eustachian tube dilation in general anaesthesia
Group II: Control GroupActive Control1 Intervention
nasal saline spray
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,840 Total Patients Enrolled
Trung N Le, MD, PhDPrincipal InvestigatorSunnybrook Health Sciences Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have problems with your jaw joint that are causing pain or dysfunction.You have cystic fibrosis, ciliary dysmotility syndrome, or a weakened immune system.Your nasal passages have blockages or structural abnormalities that would make it difficult to access the Eustachian tube through your nose.You have a birth defect called cleft palate or a condition called craniofacial syndrome affecting the face and head.You currently have a bad cold or flu.You have a condition called patulous eustachian tube.You have had previous procedures done on your eustachian tubes.You currently have a severe ear infection.You have a long-lasting ear infection with a growth called cholesteatoma.You have ongoing sinusitis, allergies, or acid reflux that isn't getting better with medication.You have received radiation treatment to your head and neck area in the past.You have been diagnosed with ongoing ear tube blockage for at least 3 months before joining the study, either in one or both ears.You have a small tube in your ear or a hole in your eardrum.You have problems with your hearing that come and go or you have been diagnosed with Meniere's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Eustachian tube dilation
- Group 2: Control Group
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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