A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Eustachian Tube Dysfunction
- Sponsor
- Integra LifeSciences Corporation
- Enrollment
- 323
- Locations
- 19
- Primary Endpoint
- Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks
Time Frame: 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 Outcomes
- 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)