NCT03200106已完成不适用
Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites
Sequana Medical N.V.3 个研究点 分布在 3 个国家目标入组 17 人开始时间: 2017年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Change in frequency of LVP after implantation of the alfapump
研究概览
简要总结
Treatment of malignant ascites with the alfapump offers a new treatment option for this patient group. So far, there is no systematic analysis of patients with this indication available in the literature.
This retrospective analysis offers the possibility to assemble already existing data within a reasonably short time frame. Based on this analysis, a prospective analysis can be designed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patients with malignant ascites
- •Patients with alfapump implanted for malignant ascites
- •Patients 18 years or older at the time of death
排除标准
- •Patient is alive at the time of inclusion assessment
结局指标
主要结局
Change in frequency of LVP after implantation of the alfapump
时间窗: 3-6 months post implant
The primary objective of the study is to evaluate the performance of the alfapump in reducing the need for large volume paracentesis (LVP) defined as paracentesis of five or more litres of ascites and not by pump paracentesis.
次要结局
- The safety and tolerability of alfapump in patients with malignant ascites(3-6 months post implant)
研究者
研究点 (3)
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