Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall Discomfort During Catheterization
研究概览
简要总结
The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
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 interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
- •Known hypersensitivity toward any of the test products -
研究组 & 干预措施
Sequence 1
SpeediCath catheter then ZN-D catheter then ZN-C catheter
干预措施: ZN-D catheter (Device)
Sequence 1
SpeediCath catheter then ZN-D catheter then ZN-C catheter
干预措施: ZN-C catheter (Device)
Sequence 1
SpeediCath catheter then ZN-D catheter then ZN-C catheter
干预措施: SpeediCath catheter (Device)
Sequence 2
SpeediCath catheter then ZN-C catheter then ZN-D catheter
干预措施: ZN-D catheter (Device)
Sequence 2
SpeediCath catheter then ZN-C catheter then ZN-D catheter
干预措施: ZN-C catheter (Device)
Sequence 2
SpeediCath catheter then ZN-C catheter then ZN-D catheter
干预措施: SpeediCath catheter (Device)
Sequence 3
ZN-D catheter then SpeediCath catheter then ZN-C catheter
干预措施: ZN-D catheter (Device)
Sequence 3
ZN-D catheter then SpeediCath catheter then ZN-C catheter
干预措施: ZN-C catheter (Device)
Sequence 3
ZN-D catheter then SpeediCath catheter then ZN-C catheter
干预措施: SpeediCath catheter (Device)
Sequence 4
ZN-D catheter then ZN-C catheter then SpeediCath catheter
干预措施: ZN-D catheter (Device)
Sequence 4
ZN-D catheter then ZN-C catheter then SpeediCath catheter
干预措施: ZN-C catheter (Device)
Sequence 4
ZN-D catheter then ZN-C catheter then SpeediCath catheter
干预措施: SpeediCath catheter (Device)
Sequence 5
ZN-C catheter then SpeediCath catheter then ZN-D catheter
干预措施: ZN-D catheter (Device)
Sequence 5
ZN-C catheter then SpeediCath catheter then ZN-D catheter
干预措施: ZN-C catheter (Device)
Sequence 5
ZN-C catheter then SpeediCath catheter then ZN-D catheter
干预措施: SpeediCath catheter (Device)
Sequence 6
ZN-C catheter then ZN-D catheter then SpeediCath catheter
干预措施: ZN-D catheter (Device)
Sequence 6
ZN-C catheter then ZN-D catheter then SpeediCath catheter
干预措施: ZN-C catheter (Device)
Sequence 6
ZN-C catheter then ZN-D catheter then SpeediCath catheter
干预措施: SpeediCath catheter (Device)
结局指标
主要结局
Overall Discomfort During Catheterization
时间窗: 1 day
Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.
次要结局
未报告次要终点