Assessing the safety and performance of the novel CytaCoat Foley catheter: A prospective randomized controlled study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- CytaCoat AB
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events (AEs) and serious adverse events (SAEs) are further divided into adverse device effects (ADEs) and serious ADEs (SADEs).
研究概览
简要总结
The study aims to assess the safety and performance of the CytaCoat Foley catheter through a randomized, controlled trial with two parallel groups.
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. Subjects in the treatment group will receive the CytaCoat Foley catheter, while subjects in the control group will receive a Sterimed uncoated Foley catheter (100% Silicone Foley Balloon catheter). The catheter will be inserted and removed by trained healthcare personnel. The catheter may be removed early, if necessary, in case of the appearance of any of the warning signs
The primary objective of this study is to determine the safety of the CytaCoat Foley catheter.
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 scale.
The study will be an interventional, single-blind, randomized, parallel assignment, and single-centre prospective clinical safety study.
Indication- For urinary incontinence and urinary drainage.
The clinical trial is designed to include a sufficient number of subjects who will be screened to enroll a total of 30 subjects for the study.
The duration of the clinical study is 6 months.
The expected duration of the subject participation is minimum of 72 hours and a maximum of 14 days of catheter use and a telephonic follow-up 7±1 days of catheter removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 84.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults, male and female, aged 18 to 84 years 2.Subjects in need of a urinary catheter for a minimum of 72 hours 3.Subjects who can accommodate a size of 14, 16 and 18 French Foley catheter 4.Written informed consent 5.Subject to be conscious.
排除标准
- •1.Pregnant or breastfeeding women 2.Critically ill subjects with a life-threatening disorder (Subjects having an APACHE II score greater equal 28) 3.Subject with a known silicone allergy or sensitivity 4.Previous enrolment in the present study 5.Simultaneous participation in another clinical study that may impact the primary endpoint 6.Subject with pre-existing urinary catheter for more than 48 hours 7.Subject with symptomatic genitourinary pathology 8.Expected severe non-compliance to the protocol as judged by the principal investigator.
结局指标
主要结局
Adverse events (AEs) and serious adverse events (SAEs) are further divided into adverse device effects (ADEs) and serious ADEs (SADEs).
时间窗: 1.Minimum of 72 hours | 2.Maximum of 14 days of catheter use | 3.Telephonic follow-up 7±1 days of catheter removal.
次要结局
- The secondary endpoint assesses the overall performance related to the medical device, based(on Foley catheter usability experience by the healthcare personnel and subjects:)