NCT03786536撤回不适用
Clinical Investigation of the Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers
MediSieve Limited0 个研究点开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Safety and tolerability, measured by incidence of Treatment-Emergent Adverse Events.
研究概览
简要总结
This is a single centre, prospective, non-randomised healthy volunteer study to be undertaken at University College Hospital London.
The study will be used to demonstrate the safe use of the MediSieve blood filtration system in healthy volunteers prior to undertaking clinical trials on patients with relevant pathologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers who meet the following criteria will be considered eligible for the study:
- •Male or female, at least 18 and ≤30 years of age;
- •Able to comprehend and sign the Informed Consent prior to enrolment in the study.
排除标准
- •Volunteers who meet the following criteria will NOT be eligible for the study:
- •Aged <18 years of age;
- •Aged >30 years of age;
- •Pregnant or lactating females;
- •Individuals < 50kg
- •Individuals with an Hb blood level below 115 g/L
- •Individuals with coagulopathies or under medication that affects normal blood coagulation profile, including COCP in females;
- •Individuals with a previous history of heparin-induced thrombocytopenia;
- •Individuals with known allergy to heparin;
- •Individuals with acute or chronic concomitant conditions; such as diabetes, hypertension, autoimmune disease requiring on going therapy
- •Individuals with history of cancer in the last 5 years;(excluding localised skin cancer or CIS)
- •Individuals with haemoglobinopathy disease;
- •Concurrent participation in another experimental intervention or drug study;
- •Unwilling or unable to provide informed consent.
结局指标
主要结局
Safety and tolerability, measured by incidence of Treatment-Emergent Adverse Events.
时间窗: During the study duration of 2 months and within the 6 month time period following treatment with the study device. following treatment
Treatment-Emergent Adverse Events during the study and the 6 month period after volunteers exit the study. Definitions from ISO14155 will be used to categorise Adverse Events
次要结局
- Performance of device during use. Time required for the user to set up and shut down the haemofiltration pump..(Through study completion, an average of 6 months...)
- Performance of device during use will be assessed by the incidence of flow-rate alarms on the haemofiltration pump during use.(Through study completion, an average of 6 months)
研究者
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