NCT04326946进行中（未招募）不适用
International Alfapump Cohort Study: in Patients With Refractory Ascites Due to Liver Cirrhosis or Malignant Ascites With a Life Expectancy of 6 Months or Less
Sequana Medical N.V.2 个研究点 分布在 2 个国家目标入组 400 人开始时间: 2018年8月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Patient survival at 6 months post implant
研究概览
简要总结
This Registry is designed to follow patients who have been implanted with an alfapump system, which is a newly marketed product from Sequana Medical AG, a Swiss Medical Device company.
详细描述
In a real-world setting, all patients implanted with an alfapump system according to it's intended use, not participating in another clinical study in which the alfapump is studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients implanted with an alfapump are eligible for this registry
排除标准
- •Patients younger than 18 years
- •Pregnancy
- •Inability to operate the Smart Charger to recharge the alfapump
- •Participating in another study in which the alfapump is studied
结局指标
主要结局
Patient survival at 6 months post implant
时间窗: 6 months post-implant
The primary outcome will be patient survival with a functional alfapump system at 6 months.
次要结局
- Clinical impact on liver and renal function in liver & renal blood lab panel(2 years)
- Impact of the alfapump on ascites symptoms related quality of life on patient activity(1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant)
- To assess safety at 1-month post implant for procedure related incidents.(1 month post implant)
- Clinical impact on ECOG(2 years)
- To assess occurrence of (major) reportable events.(2 years)
- Impact of the alfapump on ascites symptoms related quality of life(2 years)
研究者
研究点 (2)
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