Catheter Associated Urinary Tract Infections
试验速览
- 阶段
- 2 期
- 发起方
- Nanovibronix
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- primary end points
研究概览
简要总结
According to the Israeli Ministry of Health requirement, this study was designed to evaluate the efficacy of the UroShield system is patients that require urinary catheterization. This was designed to compare standard treatment (urinary catheter alone) with the UroShield treatment in occurrence of catheter associated Urinary Tract infection, pain, discomfort, Biofilm prevention and trauma.
详细描述
This study is aimed at assessing the effectiveness of the NanoVibronix™ UroShield™ System in comparison to Urinary catheter alone in patients requiring urinary catheterization.
- Primary objectives
-
To observe the effect of UroShield in reduction of patient's complaints relating to indwelling Urinary Catheters
-
Pain
-
Discomfort
-
To observe the effect of UroShield in the reduction/prevention of Biofilm
-
To observe the effect of UroShield on the occurrence of bacteriuria and/or UTI's on patients with Indwelling Urinary Catheters
- Safety Objective To assess the safety parameters of the UroShield system
- Secondary Objectives
- To observe the effect of UroShield in reduction of Foley Catheter related pain medication in patients with Indwelling Urinary Catheters
- To observe the effect of UroShield in reduction of antibiotic medication in patients with Indwelling Urinary Catheter
- To observe the effect of UroShield on the clogging of Urinary Catheter when used chronically and the need to replace the catheter
- To observe the effect of UroShield on the decrease of Tissue damage of patients with Indwelling Urinary Catheters by measuring cell count before and after removal of catheter
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Hospitalized patients age 18 years or older
- •Patients requiring or having catheterization for more than 24 hours
- •Patient able, agrees and signs the Informed Consent Form
排除标准
- •Pregnant or breastfeeding women. Women of child bearing potential will perform a pregnancy test before inclusion into the study
- •Presence of any clinically relevant known urinary tract infection
- •Patient with condition who is not expected to survive the study period
- •Known HIV positive
- •Patient has any condition, which precludes compliance with study and/or device instructions.
- •Patient is currently participating in another clinical study.
- •Known allergy to latex
结局指标
主要结局
primary end points
时间窗: up to 14 days
次要结局
未报告次要终点