Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.
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
- •Have given written informed consent and signed letter of authority
- •Be at least 18 years of age and have full legal capacity
- •Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
- •Have a negative urine multistix - erythrocytes (Microscopic haematuria)
- •Have a negative urine multistix:
- •Leukocytes
- •Nitrite Or if positive, subsequent negative for bacterial growth in urine culture
排除标准
- •Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- •Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- •Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
- •Known hypersensitivity toward any of the test products -
研究组 & 干预措施
First Coloplast Test catheter; then Speedicath catheter
The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter
干预措施: Coloplast Test Catheter (Device)
First Coloplast Test catheter; then Speedicath catheter
The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter
干预措施: Coloplast Speedicath (Device)
First Speedicath catheter; then Coloplast Test catheter
The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter
干预措施: Coloplast Test Catheter (Device)
First Speedicath catheter; then Coloplast Test catheter
The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter
干预措施: Coloplast Speedicath (Device)
结局指标
主要结局
Pain
时间窗: 1 day
The VAS scale is used to measure the pain experienced by the subjects at catheterisation
次要结局
未报告次要终点