A Prospective, Uncontrolled, Open-label Healthy Volunteer Study to Assess the Performance of the PureWick™ Male and PureWick™ Flex Female External Catheter Devices in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Performance of the PureWick System in Adolescents After HCP Placement and Self-placement
研究概览
简要总结
A prospective, uncontrolled, open-label healthy volunteer study to assess the performance of the PureWick Male and PureWick Flex Female external catheter devices in adolescents
详细描述
The objective of this healthy volunteer study is to understand if external catheters are an effective alternative in the adolescent population in both male and female adolescents. The main question it aims to answer is: Do the PureWick Male and PureWick Flex female external catheters effectively capture urine in the adolescent population after both healthcare professional placement and self-placement? Participants will void while wearing the external catheter two times and answer brief questionnaires assessing perceived wetness, IFU comprehension, comfort and ease of use. Total study participation time is 2-3 hours in a single day.
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
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adolescent Male or Female aged 12 through 21 years old
- •Able to independently and voluntarily void urine
- •Ability to speak and understand English.
- •Willing to comply with all study procedures in the protocol.
- •Provision of signed and dated informed consent form.
排除标准
- •Has urinary retention
- •Incontinent to feces
- •Has any irritation, wound, open lesion at the device application site.
- •For females: currently menstruating without use of an internal device, e.g. tampon or menstrual cup, during the execution of the study.
- •For females: currently pregnant at time of consenting (self-reported)
- •Currently enrolled in or has previously been enrolled in or has completed nursing or other clinical training and courses.
- •Has ever been employed as a home health aide or homecare provider.
- •Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
结局指标
主要结局
Performance of the PureWick System in Adolescents After HCP Placement and Self-placement
时间窗: Approximately 2 hours after device placement
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each void, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants void into the device while laying in a bed with the absorbent pad underneath them. After each void, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) \* 100.
次要结局
- Participant Comfort(Approximately 2 hours after device placement)
- Participant Ease of Use(Approximately 2 hours after device placement)
- IFU Comprehension(Approximately 2 hours after device placement)
- HCP Ease of Use(From date of first enrollment until the date of last patient completion, approximately 4 weeks)
- IFU Comprehension(Approximately 2 hours after device placement)
- HCP Ease of Use(From date of first enrollment until the date of last patient completion, approximately 4 weeks)
- Participant Comfort(Approximately 2 hours after device placement)
- Participant Ease of Use(Approximately 2 hours after device placement)