NCT03890107已完成不适用
Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- OtoSight imaging exam
研究概览
简要总结
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (17 years old or younger) scheduled for tympanostomy tube placement
排除标准
- •Otoscopy contra-indicated or not possible per attending physician's decision
结局指标
主要结局
OtoSight imaging exam
时间窗: 1-5 minutes
Optical coherence tomography imaging to evaluate the middle ear.
次要结局
- Adverse events(Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer))
研究者
研究点 (2)
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