XprESS Eustachian Tube Dilation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Change From Baseline in Mean Overall ETDQ-7 Scores
研究概览
简要总结
Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.
详细描述
Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Have been diagnosed with symptoms of chronic Eustachian tube dysfunction for no less than 12 months prior to enrollment
- •Have an overall ETDQ-7 score ≥3.0
- •Have record of failed medical management for Eustachian tube dysfunction
排除标准
- •Require concomitant procedures at the time of the study enrollment or procedure
- •Have patulous Eustachian tube
- •Have ear tubes in place or perforation of the tympanic membrane
- •Have evidence of internal carotid artery dehiscence
- •Be pregnant at the time of enrollment
- •Be currently participating in other drug or device studies
研究组 & 干预措施
XprESS
Balloon dilation of the Eustachian tube
干预措施: XprESS (Device)
Control
Continued medical management
干预措施: Control (Other)
结局指标
主要结局
Change From Baseline in Mean Overall ETDQ-7 Scores
时间窗: 6 weeks post procedure (treatment arm) or randomization (control arm)
Comparison of mean change in overall ETDQ-7 scores from baseline to 6 weeks between randomized arms. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.
Complication Rate
时间窗: Through 6 months post-procedure
Number of subjects who experience serious device- or procedure-related adverse events
次要结局
- Revision Rate(12 months)
- Technical Success Rate(Immediately after procedure)
- Mean Change in Overall ETDQ-7 Score(6 weeks postdilation)