NCT02957578Unknown不适用
Post-Market Approval Study of the Solo Tympanostomy Tube Device
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intraoperative Device Success
研究概览
简要总结
This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Listed for bilateral tympanostomy tube insertion only
排除标准
- •Anatomy that precludes sufficient visualisation of both the left and right eardrum with the Solo TTD in place.
- •Anatomy that precludes safe access to both the left and right eardrum with the Solo TTD
- •Patients in whom a reliable audiogram is not possible
研究组 & 干预措施
Solo TTD
Experimental
Placement of tympanostomy tube with Solo TTD
干预措施: Solo TTD (Device)
结局指标
主要结局
Intraoperative Device Success
时间窗: Intraoperative
Number of ears in which tube placement is achieved with the Solo TTD
次要结局
- Conversion from moderate sedation(Intraoperative)
研究者
研究点 (2)
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