NCT04148417进行中（未招募）不适用
Clinical Study of the Solo+ Tympanostomy Tube Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device
研究概览
简要总结
The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
详细描述
The study will be a multi-site, prospective, treatment-only study of the Solo+ Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.
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
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Listed for bilateral tympanostomy tube insertion
排除标准
- •Anatomy that precludes sufficient visualisation of both the left and right eardrum
- •Narrow ear canals
- •Anatomy that precludes safe access to both the left and right eardrum
- •Membrane >25% sclerosis
- •Congenital or craniofacial abnormalities
- •No available baseline audiometry and tympanometry
结局指标
主要结局
Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device
时间窗: Intra-operative
The number of ears in which the Solo Tympanostomy Tube Device tube is placed
Rate of Adverse Events
时间窗: 24 months
The number and type of Adverse Events
次要结局
未报告次要终点
研究者
研究点 (4)
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