NCT04722770已完成不适用
Clinical Development and Evaluation of a Deep Learning Approach to Improve Diagnostic Accuracy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- PhotoniCare OtoSight imaging exam
研究概览
简要总结
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. 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
- 6 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients presenting for an office visit with ear-related complaints
排除标准
- •Otoscopy contra-indicated or not possible per attending clinician's decision, Down's syndrome (due to abnormalities in ear canal anatomy)
结局指标
主要结局
PhotoniCare OtoSight imaging exam
时间窗: 1-5 minutes; at first and only study visit
Optical coherence tomography imaging to evaluate the middle ear.
次要结局
- Adverse events(15-30 minutes; at first and only study visit)
研究者
研究点 (1)
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