Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
169 participants
OBSERVATIONAL
2018-06-05
2020-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Eustachian tube dilation
Unilateral or bilateral balloon dilation of the Eustachian tube using the FDA-cleared XprESS ENT Dilation System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been diagnosed with persistent/chronic Eustachian tube dysfunction (duration 3 months or more)
* Be a candidate for unilateral or bilateral Eustachian tube balloon dilation using the XprESS device
* Be able to read and understand English
* Be willing and able to provide informed consent
* Be willing to comply with the protocol requirements
Exclusion Criteria
* Require additional ear surgery (eg, myringotomy, tympanostomy) at the time of study procedure
* Have evidence of internal carotid artery dehiscence
* Be currently participating in any other drug or device clinical studies, excluding postapproval or marketing registry studies
18 Years
ALL
No
Sponsors
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North American Science Associates Ltd.
NETWORK
Entellus Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Edward D McCoul, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ochsner Health System, New Orleans, LA
Locations
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Breathe Clear Institute
Torrance, California, United States
Colorado ENT and Allergy
Colorado Springs, Colorado, United States
Augusta ENT and Allergy
Evans, Georgia, United States
St. Vincent Anderson Hospital
Anderson, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Ear Nose and Throat Consultants
Southfield, Michigan, United States
St Cloud ENT
Saint Cloud, Minnesota, United States
ENT Consultants of Nevada
Las Vegas, Nevada, United States
Lakeside ENT
Canandaigua, New York, United States
National Allergy and ENT
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.
Other Identifiers
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4079-001
Identifier Type: -
Identifier Source: org_study_id
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