Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

Completed · Not applicable

Conditions studied: Eustachian Tube Dysfunction

In brief

The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.

Key facts

Study ID

NCT02087150

Run by

Integra LifeSciences Corporation

People needed

323

Starts

2014-02-01

Expected to finish

2017-01-12

Last updated by the study team

2024-07-12

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male or female aged 22 years and older
• 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

You may not qualify if…

• Females who are pregnant or lactating
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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