INVSENSOR00027 Fall Detection Clinical Performance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Sensitivity of INVSENSOR00027's Fall Detection.
研究概览
简要总结
This study assesses INVSENSOR00027's clinical performance for fall detection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 45 years old
- •Physical status of ASA I or II
- •Subjects must be able to read and communicate in English
- •Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement
- •Has completed Health Assessment Questionnaire and passed health assessment screening
排除标准
- •Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
- •Inability to tolerate physical activities including jumping and fall simulation
- •Nursing female volunteers
- •Excluded at the Principal Investigator's discretion
- •Refusal to take the pregnancy test (for female subjects)
- •Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.
- •Refusal to shave hair (chest) off areas where sensors will be applied (male subjects)
研究组 & 干预措施
INVSENSOR00027 Test group
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
干预措施: INVSENSOR00027 (Device)
结局指标
主要结局
Sensitivity of INVSENSOR00027's Fall Detection.
时间窗: 1-5 hours
For each subject's fall simulation, INVSENSOR00027 output will be computed. In order to calculate sensitivity of the device, true positives and false negatives need to be accounted for. For each event of fall, the sensor's output is observed. Fall that is correctly identified is marked as true positive (TP), whereas a missed detection is marked as false negative (FN). Combining the two, test sensitivity is computed by multiplying TP by 100 and dividing that over the sum of TP and FN.
次要结局
未报告次要终点