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临床试验/NCT03461549
NCT03461549已完成不适用

Open-label Preliminary Assessment of a Thin Flexible Pressure and Temperature Sensor for Therapeutic Compression Garments Using a Cohort of Healthy Adults Phase 2: Point-of-Care Wearable Pressure/Temp Sensor System for Therapeutic Compression Garments in Venous Leg Ulcers

Northwestern University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Pressure comparison with PicoPress

研究概览

简要总结

Pilot study of a soft, flexible pressure and temperature sensor

详细描述

Assessment of safety, and preliminary accuracy of a pressure and temperature sensor adherent to the skin. The pressure sensor includes a piezoresistive fabric coupled to a near-field communication chip with a built-in temperature sensor.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults over the age of 18 years old

排除标准

  • Subjects with history of medical or surgical problems

结局指标

主要结局

Pressure comparison with PicoPress

时间窗: 72 hours

Percent variation for each subject for pressure

Temperature with a comparator device (infrared camera)

时间窗: 72 hours

Percent variation for each subject for temperature

次要结局

  • Visual analogue scale of skin irritation(72 hours)
  • Participant survey(15 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shuai (Steve) Xu

Instructor

Northwestern University

研究点 (1)

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