Evaluation of a Wetness Sensing System for Continence Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Sensor Detection
研究概览
简要总结
The investigational product to be evaluated in this study is FitRight® ConnectTM Wetness Sensing System which includes: the FitRight® ConnectTM Pod, the FitRight® ConnectTM App, the FitRight® ConnectTM charger/adapter and the FitRight® ConnectTM Sensing Brief-(Medline Industries, LP) henceforth, referred to as FitRight® System, Pod, App, Charger, Alert Indicator and Brief. The purpose of this study is to validate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (~90-360 milliliters (mL)) normal saline via simulated urinary void to trigger an alert to change the brief.
详细描述
Each participant will be provided with the FitRight® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System. Each participant will be asked to wear at least three briefs so that they are wearing each brief during the simulated voids performed by the site staff. The site staff will perform the simulated void by addition of (90-360 mL normal saline to the brief. The FitRight® System will be assessed for alerts while participants are in the following positions: supine, sitting, and laying on either left or right side. Each participant will be randomized to either the left or right side. Twenty-two of the fifty-six participants will perform rewet testing procedures. The study results will be used to assess the reliability of the device's absorption to trigger an alert
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
- 是
入选标准
- •Individuals at least18 years of age
- •Individual can dress and undress self with no assistance
- •Individuals can ambulate without assistance
- •Individual can sit unsupported in a chair or on bedside with no assistance
- •Individual can lay supine and propel self up with no assistance
- •Individual can lie left/right lateral and propel self up with no assistance
- •Individuals who have hip dimensions between 32" and 70" (81-178 cm
排除标准
- •Individual is sensitive to the components of the study product(s).
- •Individual is considered inappropriate by the Principal Investigator (PI).
- •Individual has self-reported current skin condition(s) or issues around the sacral or perineal areas, such as open sores, sacral pressure injuries, rash, burns, surgical wounds and/or compromise of skin integrity.
- •Individuals who cannot complete all phases of the study requirements.
- •Individual requires use of an absorbent undergarment or catheter as the primary incontinence management strategy
- •Individuals who are pregnant
结局指标
主要结局
Sensor Detection
时间窗: 5 minutes after each amount (90-360 milliliters) saline is poured into the brief. There could be up to four pours for each brief and 3 briefs (one for each position).
Evaluate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (\~90-360mL) normal saline via a simulated urinary void to trigger an alert to change the brief in the sitting, supine, and right or left side positions.
次要结局
- Rewet Test(10 minutes after the 360 milliliters saline is poured into the brief.)