A Clinical Investigation to Collect Real-life Measurement Data to Allow Development of Mathematical Algorithms for the Updated TENA SmartCare Change Indicator.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Urine weight
研究概览
简要总结
This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.
详细描述
The purpose of this exploratory clinical investigation is to evaluate safety and to collect real-life measurement data using the updated TENA SmartCare Change Indicator. The collected data will be used to assess and develop the device related algorithms. These algorithms have been tested in a laboratory setting but real-life measurement data are to be collected to the aid in further product development.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to provide informed consent to participate or, if unable to provide such consent, have a legal representative who is willing and able to provide informed consent on behalf of the resident.
- •Be 18 years of age of older.
- •Be cared for at the investigation site.
- •Suffer from urinary incontinence.
- •Be current user of TENA Slip, Flex, Pants or Comfort incontinence products or during the course of the study be willing to become user of TENA Slip Flex, Pants or Comfort incontinence products.
- •If applicable, be on a stable regimen of medications for urinary incontinence.
排除标准
- •Have frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator.
- •Have severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss & infection).
- •Have any type of indwelling or external urinary catheter(s).
- •Be anuric.
- •Be of childbearing potential as determined by the investigator.
- •Be managed using another automated or digital health technology incontinence management device.
- •Have responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical.
- •Have any other condition that makes participation in the clinical investigation
- •Have a life expectancy of less than 90 days or be in receipt of palliative/terminal care.
- •Have participated in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the clinical investigation.
- •Be dependent on either alcohol or recreational drugs.
结局指标
主要结局
Urine weight
时间窗: 15 days
Absorbing hygiene products used by the subjects are collected in the investigation and the urine weight is determined. The urine weight is then matched with the data measured by the sensor to obtain connect sensor raw data with a specific urine content of an absorbing hygiene products
次要结局
- Caregiver assessment on urine saturation(15 days)
- Number of safety related events(15 days)
- Caregiver usability for sensor(15 days)
- Resident satisfaction with sensor(15 days)