Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane - eMPORA Study (Modified POlysulfone membRAne)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Removal rate of 2-microglobulin
研究概览
简要总结
The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone membrane to obtain CE-certification according to the European Medical Device Directive for the FX Coral 600 (TD 16-1) dialyzer.
详细描述
The FX Coral (TD 16-1) dialyzer is a new development with a modified polysulfone membrane and is not CE marked yet. The purpose of the clinical evaluation is to generate clinical data for the CE approval.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Minimum age of 18 years
- •Informed consent signed and dated by study patient and investigator / authorized physician
- •Ability to understand the nature and requirements of the study
排除标准
- •Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general good condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.).
- •Ongoing participation in an interventional clinical study during the preceding 30 days
- •Previous participation in this study
- •Pregnancy (pregnancy test will be conducted with female patients aged less or aged 55 years) or lactation period
结局指标
主要结局
Removal rate of 2-microglobulin
时间窗: t=240 min. of HDF
Removal rate of 2-microglobulin will be calculated as primary endpoint in blood samples to evaluate the clinical performance of the new FX Coral 600 (TD 16-1) dialyzer.
次要结局
- Removal rates of myoglobin(t=240 min. of HDF)
- Clearances of myoglobin(t= 60 min. of HDF)
- Clearance of ß2-microglobulin(t=60 min. of HDF)