Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of Participants With Readability of Pressure Sensor Measurements
研究概览
简要总结
The purpose of the investigational device in the proposed clinical investigation is to capture pressure data prior to and during voiding using a CE-marked commercially available catheter.
详细描述
This clinical investigation is based on an open explorative design evaluating the sensor ability to record readable data in healthy volunteers and the extent of artifacts influencing data quality and readability in healthy volunteers.
Overall:
- Single arm. Open-labelled, not randomized
- Healthy volunteers
Duration:
Information visit:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Have given written informed consent
- •Be at least 18 years of age and have full legal capacity
排除标准
- •Previous history of genitourinary disease in-cluding congenital abnormalities and surgical procedures performed in the urinary tract
- •Symptoms of urinary tract infections (fre-quent urination, stinging and pain at urina-tion)
- •Participation in any other clinical investiga-tions during this investigation (Inclusion → termination)
- •Known hypersensitivity toward any of the test products
- •Positive pregnancy tes for women
结局指标
主要结局
Number of Participants With Readability of Pressure Sensor Measurements
时间窗: 1 hour
Determination of whether the sensor could detect changes in pressure in kilopascal (kPa) and provide a readable graph depicting changes in kPa over time of use of IC. Each pressure sensor graph is assessed visually to determine whether the instrument can be used in future studies on a Yes/No basis. The total number of participants with readable pressure sensor measurements were counted.
次要结局
未报告次要终点