NCT01030185已完成2 期
A Prospective, Multi-center, Open Label, Non-randomized Study to Investigate the Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance
NovaShunt AG18 个研究点 分布在 4 个国家目标入组 40 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 18
- 主要终点
- The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events
研究概览
简要总结
To investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance.
Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.
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
- •Patients ≥ 18 years of age
- •Recurrence of ascites defined as clinical reappearance of ascites within 4 weeks of initial paracentesis.
- •Cirrhosis of any etiology
- •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 <88mEq/d.
- •Serum creatinine levels of ≤ 2.0 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
- •Ability to comply with study procedures and ability to operate the device.
- •Women of childbearing age should use adequate contraceptives
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
- •Advanced hepatocellular carcinoma, demonstrated by:
- •One tumor that is >5 cm diameter
- •3 or more nodules of >3 cm diameter
- •Portal thrombosis
- •Other evidence of a malignant Etiology for Ascites
- •Evidence of extensive ascites loculation
- •Gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to the inclusion in the study.
- •Hepatic encephalopathy in the two weeks prior to implant
- •Presence of a TIPS or surgical portosystemic shunt
- •Presence of Budd-Chiari syndrome
- •Previous liver transplant
- •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
- •Patients being in another clinical study that did not reach primary endpoint yet
结局指标
主要结局
The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events
时间窗: 6 months
次要结局
- Paracentesis requirements(6 month)
- Hematology(6 month)
- Incidence of hemodynamic instability(6 month)
- Incidence and severity of peripheral edema(6 month)
- Patient Quality of Life.(6 month)
研究者
研究点 (18)
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