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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Urine Volume Quantification and Impedance Measurements
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 TENA SmartCare Change Indicator. The collected data will be used to assess the device related algorithms. These algorithms have been established and verified in a laboratory environment. However, due to possible differences in parameters, real-life measurement data are to be collected to 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
- Device Feasibility
- 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
- •The subject is willing and able to provide informed consent and to participate in the clinical investigation.
- •The subject is ≥18 years of age.
- •The subject is diagnosed with urinary incontinence.
- •The subject is being cared for at Tre Stiftelser.
排除标准
- •The subject has ≥ 4 fecal "incidences" per week.
- •The subject has severe absorbent product related skin problems, as judged by the investigator.
- •The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
- •The subject has ≥ 2 intermittent urinary catheters per day.
- •The subject has a pacemaker or an implantable cardioverter-defibrillator.
- •The subject removes the incontinence product.
- •The subject demonstrates responsive behavior towards sensors.
- •The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
- •The subject is not cared for at Tre Stiftelser.
- •The subject is pregnant or lactating.
结局指标
主要结局
Urine Volume Quantification and Impedance Measurements
时间窗: 11 weeks
Descriptive statistics were used to summarize any individual differences between the predicted urine volume from the Change Indicator and the true urine volume (by measuring absorbent product weight). A measure of mean difference for the predicted volume minus true volume is assessed. A combination of these values were used to assess the mathematical algorithms for the TENA SmartCare Change Indicator.
次要结局
未报告次要终点