NCT00870662已完成不适用
A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal
NovaShunt AG2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2008年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Number of paracentesis procedures required
研究概览
简要总结
The purpose of this study is to determine whether the Automatic Fluid Shunt (AFS) can reduce the number of paracentesis procedures in patients with refractory ascites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female or male patients ≥ 18 years of age
- •Removal of at least 10 L of ascites in the preceding 2 months for symptom relief
- •Failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects
- •Dietary sodium restriction <90 mcg/d.
- •Serum creatinine levels of less than 1.8 mg/dL for at least 7 days before study entry.
- •Total bilirubin levels of less than 3 mg/dL.
- •Expected survival of greater than 6 months
- •Written informed consent
排除标准
- •Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
- •Presence of peritoneal carcinomatosis
- •Evidence of extensive ascites loculation
- •Obstructive uropathy
- •Coagulopathy that could not be corrected to a prothrombin time INR <1.8,
- •Thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3
- •Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator
- •Any condition requiring emergency treatment
- •Pregnancy
- •Inability to obtain informed consent
研究组 & 干预措施
Automatic Fluid Shunt
Experimental
干预措施: AFS System (Device)
结局指标
主要结局
Number of paracentesis procedures required
时间窗: 6 month
次要结局
未报告次要终点
研究者
研究点 (2)
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