Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Clinical Bias
研究概览
简要总结
The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).
详细描述
The study design is based on the ISO 80601-2-56, Clause 201.102 for adjusted mode clinical thermometers. The study is designed to be a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's temperature measurement compared to a standard FDA 510(k)-cleared reference clinical thermometer (RCT).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects over 22 years of age
- •Ability to provide signed informed consent, and/or have a legally authorized representative (LAR) willing to provide informed consent on behalf of the subject
- •ESI score of 3-5
排除标准
- •Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the study procedure
- •Recent immunization within seven days of the study procedure
- •Pregnancy
- •ESI score of 1-2
结局指标
主要结局
Clinical Bias
时间窗: Up to 1 hour
Clinical Bias will be evaluated by comparing the first recorded measurement using ND with the corresponding measurement recorded by the RCT. The bias is calculated per IEC 80601-2-56, Clause 201.103.3.
Clinical Repeatability
时间窗: Up to 1 hour
Clinical Repeatability is calculated by a pooled standard deviation of the triplicate measurements over the entire population of subjects. The method to calculate Clinical Repeatability is per IEC 80601-2-56, Clause 201.102.5.
Limits of Agreement
时间窗: Up to 1 hour
Limits of Agreement (LOA) will be calculated using all three measurements by the ND and the corresponding measurements by the RCT. The LOA is calculated per IEC 80601-2-56, Clause 201.103.4.
次要结局
未报告次要终点