Status:
COMPLETED
Eustachian Tube Dilation With an Endovascular Balloon
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Eustachian Tube Dysfunction
Eustachian Tube Dysfunction of Both Ears
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- ≥18 years old (of both sexes)
- Diagnosed with unilateral or bilateral persistent obstructive eustachian tube dysfunction (OETD)
- Undergoing tympanoplasty or tympanomastoidectomy
Exclusion
- 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
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04809753
Start Date
March 29 2021
End Date
February 28 2022
Last Update
October 26 2022
Active Locations (1)
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1
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5