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临床试验/NCT03340441
NCT03340441Unknown不适用

Clinical Evaluation for Body Temperature Measurement Using Prizma Smart Phone Cover and Application

G Medical Innovations Ltd.1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年4月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Temperature measurement

研究概览

简要总结

The purpose of the study is to evaluate the temperature measurements by the Prizma device.

详细描述

Primary objective of this study is to compare the temperature measured by the PRIZMA to the oral and Armpit temperature measured by a gold standard device in order to develop and evaluate a skin to body temperature conversion table.

Secondary objective is to collect and compare data of ECG, Respiration and SpO2 collected from the Prizma device to the data collected from gold standard devices for reference of noise level and for future development of the PRIZMA device.

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
17 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed written informed consent
  • Age above 18 years from both genders
  • ASA physical status 1-4
  • Hospitalized in internal ward

排除标准

  • Abuse of alcohol or illicit drugs
  • History of mental retardation or any mental disease
  • Skin irritation / Atopic dermatitis or any other skin condition at the area of patients palms that might affect his/her ability to hold the device appropriately

结局指标

主要结局

Temperature measurement

时间窗: 3 months

Develop and evaluate a skin to body temperature conversion table.

次要结局

未报告次要终点

研究者

发起方
G Medical Innovations Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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