Explorative Clinical Study Investigating the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Urine Flow Rate
研究概览
简要总结
Performance and acceptance of new intermittent catheters tested in healthy volunteers
详细描述
This study is a single blinded, randomised, crossover study. The study period consists of an information visit, an inclusion visit, three test visits and a termination visit.
Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard catheter SpeediCath® Flex (Comparator).
In the investigation ten subjects will be included. The subjects will be catheterised once per visit. The subjects will be catheterised with the two test catheters and comparator in a randomised order. The order of the catheterisations will be randomised to prevent bias.
During the test visits the primary, secondary and explorative endpoints will be registered.
Subjects will be asked to participate in an interview in continuation of their last visit (Test Visit 3). The interviews will be performed by a Coloplast representative asking questions related to their experience with the catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits
排除标准
- •Has a previous history of genitourinary disease including congenital abnormalities and surgical procedures performed in the urinary tract Has symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Are participating in any other clinical investigation related to urinary tract system during this investigation (inclusion to termination) Known hypersensitivity toward any of the test products
研究组 & 干预措施
Test product 2
Test catheter 2
干预措施: Test product 3 (Device)
Test product 2
Test catheter 2
干预措施: Comparator (Device)
Test product 3
Test catheter 3
干预措施: Test product 2 (Device)
Test product 3
Test catheter 3
干预措施: Comparator (Device)
Comparator
SpeediCath Flex
干预措施: Test product 2 (Device)
Comparator
SpeediCath Flex
干预措施: Test product 3 (Device)
结局指标
主要结局
Urine Flow Rate
时间窗: 2 hour
On day of study visits 1-5 rate of urine flow through catheter measured in mL/s
次要结局
- Number of Participants With Hematuria(2 hour)
- Post-void Residual Urine(2 hour)