Deep Tissue Thermometry 510(k) Premarket Notification Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 3M
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Temperature Agreement in Degrees Celsius.
研究概览
简要总结
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA.
详细描述
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA. The trial design reflects elements desired by the FDA. The trial is designed to satisfy the relevant requirements of the FDA Guidance (March 1993) on the content of premarket notification [510(k)] submissions for clinical electronic thermometers and ISO/IEC 80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects with skin disruptions on the forehead, dysautonomia, spinal cord injury, or taking barbiturates, thyroid preparations, antipsychotics, or who have had a recent (1wk) immunization
结局指标
主要结局
Temperature Agreement in Degrees Celsius.
时间窗: Upon enrollment
Temperature Agreement/Bias (Zero heat flux thermometry temperature minus oral or rectal temperature) between simultaneously-acquired oral or rectal and forehead deep tissue temperatures.
次要结局
未报告次要终点