NCT05741333进行中（未招募）不适用
Pivotal In-Office 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
- 66
- 试验地点
- 7
- 主要终点
- Rate of Adverse Events
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.
详细描述
The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to <13 years.
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 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥6 months to <13 years
- •Planned tympanostomy tube insertion
- •Patient is able to commit to the follow-up visits and assessments
排除标准
- •Anatomy that precludes sufficient visualization of the tympanic membrane
- •Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
- •Narrow ear canals
- •Congenital or craniofacial abnormalities affecting the ear
- •No baseline audiometry or tympanometry
- •Familial history of insensitivity to anesthetic components
- •Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure
结局指标
主要结局
Rate of Adverse Events
时间窗: 24 months
Incidence and nature of device- or procedure-related adverse events
Procedure Success
时间窗: Intra-operative
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears
次要结局
未报告次要终点
研究者
研究点 (7)
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