Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter
NCT ID: NCT02087150
Last Updated: 2024-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
323 participants
INTERVENTIONAL
2014-02-01
2017-01-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medical management (MM)
Medical management will consist of 6 weeks of daily intranasal steroid (triamcinolone acetonide)
No interventions assigned to this group
Eustachian tube balloon catheter (ETBC) plus MM
Eustachian tube dilation with the ETBC plus medical management
Acclarent Eustachian Tube Balloon Catheter (ETBC)
Interventions
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Acclarent Eustachian Tube Balloon Catheter (ETBC)
Eligibility Criteria
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Inclusion Criteria
* Persistent Eustachian tube dysfunction
* Failure of medical management
* Positive diagnosis of ETD
* Absence of internal carotid artery (ICA) dehiscence
* Able to read and understand English
Exclusion Criteria
* Anatomy that requires an adjunctive surgical procedure
* Concomitant nasal or sinus procedures planned on the same day as surgical procedure
* Concomitant ear procedures planned on the same day as surgical procedure
* History of major surgery of the head or neck within four (4) months prior to surgery
* History of patulous ET
* History of fluctuating sensorineural hearing loss
* Active acute otitis media
* Tympanic membrane perforation
* Tympanosclerosis
* Acute upper respiratory infection
* Temporomandibular joint disorder
* Cleft palate
* Craniofacial syndrome
* Cystic fibrosis
* Ciliary dysmotility syndrome
* Systemic mucosal or immunodeficiency disease
* Intolerance of medication for ETD
* Prior intervention of Eustachian tube
22 Years
ALL
No
Sponsors
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Acclarent
INDUSTRY
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Poe, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Vijay Anand, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University
Locations
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California Ear Institute
East Palo Alto, California, United States
George Washington Medical Faculty Associates, ENT Center
Washington D.C., District of Columbia, United States
ENT of South Florida
Boca Raton, Florida, United States
ENT of South Florida
Boynton Beach, Florida, United States
Florida Ear & Sinus Center
Sarasota, Florida, United States
ENT of Georgia
Atlanta, Georgia, United States
Piedmont Ear, Nose & Throat &Related Allergy
Atlanta, Georgia, United States
Witham Health Services
Lebanon, Indiana, United States
Red River Sinus Center
Alexandria, Louisiana, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
Children's Hospital
Boston, Massachusetts, United States
Health Partners Specialty Center
Saint Paul, Minnesota, United States
The Sinus Center of the South
Ocean Springs, Mississippi, United States
Vijay Anand, LLC
New York, New York, United States
Ear, Nose, Throat and Allergy Associates, LLP
Port Jefferson, New York, United States
Ear, Nose, Throat and Allergy Associates, LLP
White Plains, New York, United States
Charlotte Eye, Ear, Nose &Throat Associates
Charlotte, North Carolina, United States
Carolina Ear and Hearing Clinic
Raleigh, North Carolina, United States
Texas Healthcare, PLLC
Fort Worth, Texas, United States
Ear Medical Group
San Antonio, Texas, United States
Meriter Monona
Monona, Wisconsin, 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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CPR005029
Identifier Type: -
Identifier Source: org_study_id
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