NCT05260099撤回不适用
Post Market Clinical Follow up (PMCF) Medical Device (MD) Registry of the Alteco® LPS Adsorber to Remove Lipopolysaccharide (LPS) in Patients With Suspected Endotoxemia, With Severe Symptom(s)/Complication(s) and Their Stabilization Outcomes: REMOVE LPS Registry
Alteco Medical AB0 个研究点开始时间: 2022年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment.
研究概览
简要总结
This registry will collect and validate regulatory-grade real-world data (RWD) on the usage of the LPS-Adsorber and the outcomes from using the LPS-Adsorber in various patient populations (various sub-registries) that also have suspected endotoxemia. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Weight > 30 kilos
- •Specific sub-registry criteria are possible.
排除标准
- 未提供
结局指标
主要结局
The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment.
时间窗: 30 days
次要结局
- Secondary Outcomes will be to document the change in a patient's symptoms of infection over time.(30 days)
- Rate of complaints and incidents related to the medical device during the whole registry.(30 days)
研究者
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