NCT07071298招募中不适用
A Real World, Observational Pediatric Registry of the Acclarent AERA® Eustachian Tube Balloon Dilation System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 13
- 主要终点
- Failure-free after ETBD with the AERA® device.
研究概览
简要总结
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Specific indications for ETBD are documented
- •ETBD with AERA device attempted-
排除标准
- •ETBD with device other than AERA®
- •Previous ETBD procedure-
结局指标
主要结局
Failure-free after ETBD with the AERA® device.
时间窗: 27 months
Failure is defined as revision ETD surgery (e.g. further ETBD, tympanostomy tube (TT) insertion, or adenoidectomy for ETD).
次要结局
- Tympanogram assessed by ear(27 months)
- Pure tone audiometry (PTA) assessed by ear(27 months)
- Valsalva maneuver assessed by ear(27 months)
- Inflammation score assessed by ear(27 months)
- Eustachian Tube Dysfunction Questionnaire (ETDQ-7) assessed by patient(27 months)
- Otitis Media- 6 Questionnaire (OM-6) assessed by patient(27 months)
研究者
研究点 (13)
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