Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter
- Conditions
- Eustachian Tube Dysfunction
- Registration Number
- NCT02087150
- Lead Sponsor
- Integra LifeSciences Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 323
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks 6 Week Follow-Up Visit The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function
- Secondary Outcome Measures
Name Time Method Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks 6 Week Follow-Up Visit The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD.
Trial Locations
- Locations (19)
California Ear Institute
🇺🇸East Palo Alto, California, United States
George Washington Medical Faculty Associates, ENT Center
🇺🇸Washington, District of Columbia, 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
Scroll for more (9 remaining)California Ear Institute🇺🇸East Palo Alto, California, United States