跳至主要内容
临床试验/NCT05260099
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

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

发起方
Alteco Medical AB
申办方类型
Industry
责任方
Sponsor

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