A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Performance/Ease of Use
研究概览
简要总结
To evaluate the performance of GentleCath Glide™ Intermittent Catheters
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of 18 years old and above who require intermittent bladder drainage may be recruited into the study
- •Subjects must be willing and able to provide written informed consent
- •Subjects may be either inpatients or outpatients but must all be capable of completing a patient diary card to record study data
- •Subjects must currently use intermittent catheters and have been using intermittent catheters for the last six months
- •Patients who self-catheterise at least three times per day
- •Able to attend final assessment visit at day 14
排除标准
- •Subjects who require intermittent catheterisation to administer irrigation or instillation.
- •Subjects who are presently participating in another clinical trial.
- •Subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
- •Subjects with known sensitivity to the device components
研究组 & 干预措施
Single Arm Study
This is a single arm study with no comparator
干预措施: Intermittent Catheter (Device)
结局指标
主要结局
Performance/Ease of Use
时间窗: 14 Days
Performance and ease of use will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
Ease of Removal
时间窗: 14 Days
Ease of removal will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
Residue Acceptability
时间窗: 14 Days
Residue acceptability will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
次要结局
未报告次要终点