NCT02400164已完成不适用
A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites
Sequana Medical N.V.7 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2015年3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
- 30
- 试验地点
- 7
- 主要终点
- Incidence and severity of serious adverse events related to the device and its implantation.
研究概览
简要总结
The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients ≥ 21 years of age
- •recurrence of grade 3 ascites requiring paracentesis for symptom relief more frequently than once per month for a minimum of 2 of the prior 3 months
- •cirrhosis of any etiology
- •failure to respond to or intolerance to high dose diuretics
- •expected survival of greater than 3 months (MELD score ≤ 21)
- •screened for varices and on optimal management
- •diagnostic paracentesis with neutrophil count < 250 / µl within 24 hours of implantation
- •written informed consent
- •ability to comply with study procedures and ability to operate the device
- •women of childbearing potential should use adequate contraception
排除标准
- •more than 2 systemic or local infections, such as peritonitis, urinary tract infection, or abdominal skin infection within the last 6 months
- •presence of any current cancer
- •evidence of extensive ascites loculation
- •serum creatinine > 1.5 mg/dl
- •serum bilirubin > 5 mg/dl
- •eGFR < 30 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) method
- •gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to inclusion in the study
- •hepatic encephalopathy > stage II in the two weeks prior to implant
- •presence of a patent TIPS or surgical portosystemic shunt
- •presence of Budd-Chiari syndrome
- •previous solid organ transplant
- •obstructive uropathy (bladder residual volume > 100ml (determined by catheterization or abdominal ultrasound) or any bladder anomaly which may contraindicate implantation of the alfapump, including recurrent urinary tract infections, vesicoureteral reflux, or history of urinary calculi)
- •International Prostate Symptom Score (I-PSS) ≥20
- •thrombocytopenia < 45,000 X106/l
- •patient undergoing therapeutic anticoagulation
- •recent (<4 months) intra-abdominal foreign body or abdominal surgery, diaphragmatic hernia, abdominal surgery, severe abdominal adhesions, surgically irreparable hernia, abdominal wall or skin infection, or severe malnutrition.
- •history (>6 months) of diaphragmatic hernia, history of bladder cancer, inflammatory or ischemic bowel disease, and frequent episodes of diverticulitis.
- •any non-liver disease with life expectancy < 1 year
- •patients eligible for TIPS (unless they have refused TIPS placement).
- •presence of any active implantable or body-worn devices that cannot be removed
- •patients being in another therapeutic clinical study
研究组 & 干预措施
alfapump system
Experimental
The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis.
干预措施: alfapump system (Device)
结局指标
主要结局
Incidence and severity of serious adverse events related to the device and its implantation.
时间窗: 12 months
次要结局
- Evaluate patient quality of life(12 months)
- Overall survival(12 months)
- Nutritional status(12 months)
- Assess the overall requirement for large volume paracentesis(12 months)
研究者
研究点 (7)
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