Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter
- Conditions
- Eustachian Tube Dysfunction
- Interventions
- Device: Acclarent Eustachian Tube Balloon Catheter (ETBC)
- 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
- Arm && Interventions
Group Intervention Description Eustachian tube balloon catheter (ETBC) plus MM Acclarent Eustachian Tube Balloon Catheter (ETBC) Eustachian tube dilation with the ETBC plus medical management
- 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)
Piedmont Ear, Nose & Throat &Related Allergy
๐บ๐ธAtlanta, Georgia, United States
Florida Ear & Sinus Center
๐บ๐ธSarasota, Florida, United States
Our Lady of the Lake Hospital
๐บ๐ธBaton Rouge, Louisiana, United States
Carolina Ear and Hearing Clinic
๐บ๐ธRaleigh, North Carolina, United States
Witham Health Services
๐บ๐ธLebanon, Indiana, United States
Children's Hospital
๐บ๐ธBoston, Massachusetts, United States
ENT of Georgia
๐บ๐ธAtlanta, Georgia, United States
George Washington Medical Faculty Associates, ENT Center
๐บ๐ธWashington, District of Columbia, United States
California Ear Institute
๐บ๐ธEast Palo Alto, California, United States
ENT of South Florida
๐บ๐ธBoynton Beach, Florida, United States
Red River Sinus Center
๐บ๐ธAlexandria, Louisiana, United States
Health Partners Specialty Center
๐บ๐ธSaint Paul, Minnesota, United States
The Sinus Center of the South
๐บ๐ธOcean Springs, Mississippi, United States
Ear, Nose, Throat and Allergy Associates, LLP
๐บ๐ธWhite Plains, New York, United States
Charlotte Eye, Ear, Nose &Throat Associates
๐บ๐ธCharlotte, North Carolina, United States
Vijay Anand, LLC
๐บ๐ธNew York, New York, United States
Meriter Monona
๐บ๐ธMonona, Wisconsin, United States
Texas Healthcare, PLLC
๐บ๐ธFort Worth, Texas, United States
Ear Medical Group
๐บ๐ธSan Antonio, Texas, United States