A Prospective Single-center Randomized Pilot Study to Evaluate the Safety and Performance of the Novel CytaCoat LIP Foley Catheter When Compared to an Uncoated Foley Catheter
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- CytaCoat AB
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of incidence of adverse events and serious adverse events (safety and tolerability) of the CytaCoat LIP Foley catheter
研究概览
简要总结
The goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use.
The primary objective of this study is to determine the safety and tolerability for the medical device CytaCoat LIP Foley catheter in patients undergoing Transurethral Resection of the Bladder (TUR-B) surgery. Safety will be assessed by evaluation of adverse events.
The secondary objective is to assess the overall performance by evaluating if there were any Foley catheter handling problems experienced by the healthcare personnel with the use of the CytaCoat LIP Foley catheter.
Exploratory objectives are to assess bacterial culture of urine samples taken before and after catheterization and to assess pain, irritation and discomfort measured by asking patients about their experience using the catheter using a questionnaire.
Participants will be catheterized with either a CytaCoat Foley catheter or an uncoated silicone catheter, for a maximum of 24 hrs. After removal of the catheter, participants will be asked to assess if they experienced any pain, irritation and discomfort measured with the Numerical Rating Scale (NRS) (0-10). A similar assessment will be performed 7-10 days after removal of the catheter. In addition, the healthcare personnel will be asked to assess the functionality of the coated catheter with the NRS scale (0-10), using a questionnaire. Urine samples will be taken before and after catheterization and evaluated through quantification.
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 LIP Foley catheter or the comparator) but the participant will not know which catheter they have received.
The healthcare practitioner removing the catheter will not know the allocation. Urine samples that are analysed will not state which arm the participant 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
- 否
入选标准
- •Will be undergoing a TUR-B procedure.
- •Able to give informed consent by signing and dating the written informed consent document acknowledging their desire to participate in the study.
- •Adults, age 18 to 84 years.
- •Require insertion of a size 12, 14, 16, 18 or 20 French Foley catheter after TUR-B surgery.
- •Be able to understand and comply with the information given in the Patient Consent Form.
排除标准
- •Vulnerable subjects such as children, pregnant or breastfeeding women, or potentially immune-compromised subjects.
- •Unable to provide informed consent.
- •Has a known bacteriuria or a current urinary tract infection.
- •Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy.
- •Has an ongoing antibiotic therapy.
- •Cannot accommodate a size 12, 14, 16, 18 or 20 Fr Foley catheter or requires a Thiemann tip Foley catheter.
- •Previous enrolment in the present study.
- •Simultaneous participation in another clinical study that may impact the primary endpoint.
- •Severe non-compliance to protocol as judged by the PI.
结局指标
主要结局
Assessment of incidence of adverse events and serious adverse events (safety and tolerability) of the CytaCoat LIP Foley catheter
时间窗: 1 - 10 days
Adverse events (AEs) and serious adverse events (SAEs) will be assessed, which are further divided into adverse device effects (ADEs) and serious ADEs (SADEs).
次要结局
- Assessment of the overall performance of the CytaCoat LIP Foley catheter(1 - 10 days)