Clinical Study of the Solo Tympanostomy Tube Device
试验速览
- 阶段
- 不适用
- 入组人数
- 27
- 试验地点
- 3
- 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 post-approval evaluation of 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
研究组 & 干预措施
Solo Tympanostomy Tube Device
The Solo Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure
干预措施: Solo TympanostomyTube Device (Device)
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: Intra-operative, 2-6 weeks post-operative
The number and type of Adverse Events
次要结局
未报告次要终点