Assessing the Safety and Performance of the Novel CytaCoat Foley Catheter: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CytaCoat AB
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assessment of Safety through incidence of adverse events and serious adverse events of the CytaCoat Foley catheter.
研究概览
简要总结
This study is a prospective, single-center, single-blind, randomized, parallel assignment, controlled study to evaluate the safety and performance of the novel CytaCoat Foley catheter when compared to a Sterimed uncoated Foley catheter. Participants will include male and female adult subjects who require an indwelling urinary catheter for an expected duration of minimum 72 hours to 14 days.
The primary purpose of the clinical investigation is to determine whether the novel CytaCoat Foley catheter is safe to use in subjects. Safety is assessed by evaluation of adverse events (according to ISO 14155:2020).
The secondary objective is to assess the overall performance of the CytaCoat Foley catheter by evaluating usability experience by the healthcare personnel and subjects measured by using NRS (Numeric Rating Scale) scale.
Furthermore, the exploratory objective of this study is to assess for the presence of bacteriuria in urine and fouling / biofilm analysis of the used catheters.
详细描述
Study description This clinical study is designed to evaluate the safety and performance of the CytaCoat Foley catheter in subjects requiring urinary catheterization. The study will be conducted as a randomized, controlled trial with two parallel groups, wherein one group will receive the CytaCoat Foley catheter, and the other will receive a standard silicone Foley catheter as the control.
The study aims to determine the incidence of adverse events and to assess the overall performance of the CytaCoat Foley catheter in terms of patient outcomes, ease of use, and durability. The study will include patients who meet the inclusion criteria, with a defined follow-up period to assess the outcomes.
The primary purpose of the clinical study is to determine whether the novel CytaCoat Foley catheter is safe to use in subjects. The claims regarding clinical performance and clinical safety that the manufacturer intends to use:
- More comfortable
- Easy insertion and removal
Primary Objective The primary objective of this study is to determine the safety for the CytaCoat Foley catheter. Safety is assessed by evaluation of adverse events (according to ISO 14155:2020). Adverse events (AEs) and Serious Adverse Events (SAEs) are further divided into Adverse Device Effects (ADEs) and Serious ADEs (SADEs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The healthcare practitioner placing the catheter will know the allocation (whether it is a CytaCoat Foley catheter or the comparator) but the subject will not know which catheter they have received. The healthcare practitioner removing the catheter may or may not know the allocation. Analyzed catheters for fouling / biofilm assessment will not state which arm the subject is in.
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, male and female, aged 18 to 84 years
- •Subjects in need of a urinary catheter for a minimum of 72 hours
- •Subjects who can accommodate a size of 14, 16 and 18 French Foley catheter
- •Written informed consent
- •Subject to be conscious
排除标准
- •Pregnant or breastfeeding women
- •Critically ill subjects with a life-threatening disorder (Subjects having an APACHE II score ≥ 28)
- •Subject with a known silicone allergy or sensitivity
- •Previous enrolment in the present study
- •Simultaneous participation in another clinical study that may impact the primary endpoint
- •Subject with pre-existing urinary catheter for more than 48 hours
- •Subject with symptomatic genitourinary pathology
- •Expected severe non-compliance to the protocol as judged by the principal investigator
结局指标
主要结局
Assessment of Safety through incidence of adverse events and serious adverse events of the CytaCoat Foley catheter.
时间窗: 3 - 14 days
Adverse events (AEs) and serious adverse events (SAEs) which are further divided into adverse device effects (ADEs) and serious ADEs (SADEs) will be assessed.
次要结局
- Assessment of the overall performance related to the CytaCoat Foley catheter using questionnaires.(3 - 14 days)