A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 39
- 主要终点
- Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks
时间窗: 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
次要结局
- 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)