NCT01960517撤回2 期
A Feasibility Assessment of a New Urinary Catheter: The Alternative Catheter System ACS)
Alternative Urological Catheter Systems Ltd.2 个研究点 分布在 1 个国家开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Retention of the ACS catheter
研究概览
简要总结
This is a single centre, non-randomised, baseline controlled, prospective pilot clinical trial to be undertaken at Rotherham General Hospital, Rotherham, UK.
The study will examine the safety and performance of a new urinary catheter, the Alternative Catheter System (ACS) (Alternative Urological Catheter Systems Ltd (AUCS), Bristol, UK) which has been developed to reduce the morbidity of long-term catheterisation and the acknowledged deficiencies of the conventional Foley urinary catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Male or female, at least 18 years of age.
- •Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.
- •Capable of using a catheter valve to empty the bladder and able to communicate their experience with the system OR who has a carer able to fulfil these tasks.
- •Fitted with a suprapubic catheter (at least 2 weeks post insertion).
- •Ability to attend out-patient clinic at regular intervals throughout the study and able to participate for a maximum of 8 weeks.
- •History of catheter blockages, bypassing or episodes of pyrexia and bacteraemia in the last 2 months.
排除标准
- •<18 years of age.
- •Pregnant or lactating females.
- •History of catheter associated septicaemia in the past month.
- •Evidence of current systemic infection.
- •Bladder pathology such as a tumour or stone >0.5cm as determined by cystoscopy.
- •Flaccid bladder.
- •Current participation in another device or drug study.
- •Unwilling or unable to provide informed consent.
结局指标
主要结局
Retention of the ACS catheter
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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