NCT04722770
已完成
不适用
Clinical Development and Evaluation of a Deep Learning Approach to Improve Diagnostic Accuracy
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Otitis Media Acute
- 发起方
- PhotoniCare, Inc.
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- PhotoniCare OtoSight imaging exam
- 状态
- 已完成
- 最后更新
- 2年前
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.
研究者
入排标准
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)
研究点 (1)
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