Prospective Study in the Use of the Alfapump® in the Treatment of Malignant Ascites
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Monthly therapeutic paracentesis frequency up to 3 months
研究概览
简要总结
ProMAS is a prospective post-marketing, single-arm study to assess performance and safety of the Alfapump® system in the treatment of patients with malignant ascites. The study aims to enroll 40 patients in up to 8 sites in Europe.
详细描述
The Prospective Malignant Ascites Alfapump® study is a single-arm, prospective study to evaluate the performance and safety of the Alfapump® system in the treatment of patients with malignant ascites. The Alfapump® system is a fully implantable programmable pump, able to move ascitic fluid from the peritoneal cavity to the bladder via 2 catheters. The Alfapump® has obtained CE (Conformité Européenne) mark approval for the indication of malignant ascites. The primary objective of the study is to assess the performance of the system to remove ascites. Secondary objectives are to evaluate the safety and tolerability of the Alfapump® in the treatment of malignant ascites for a total follow-up period of 9 months, and to evaluate quality of life (QoL) by reduction or elimination of paracentesis requirement. Furthermore the study includes an exploratory scientific objective as to feasibility to obtain 'liquid biopsy' samples suitable for analysis in a non-invasive way after Alfapump® implantation. 40 patients with malignant ascites will be enrolled in up to 8 sites in Europe (Belgium, United Kingdom, Switzerland). Specific sub-analysis of data from patients with gynecological (ovarian) cancer is planned.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject is ≥ 18 years of age;
- •Subject has provided written informed consent; 3.Subject has recurrent malignant ascites defined as ≥2 therapeutic paracenteses in the month prior to enrolment; 4.Subject has sufficient baseline data documented for at least 4 paracentesis events in the last 3 months pre-implant, including date and volume; 5.Subject has ascites following neoplastic disease, as assessed by physician. In subjects with primary malignancy of the liver it should be confirmed that the ascites is due to malignancy and not due to underlying pre-existing cirrhosis.
- •6.Subject has a life expectancy of ≥3 months as assessed by the treating physician, and is receiving or intended to receive anticancer therapy.
- •7.Subject has the ability to comply with study procedures, including all follow-up visits at implanting centre when required, and ability to perform subject-required system tasks (charging). A subject with a caregiver who can comply with the study procedures and to perform the tasks required for appropriate pump function is allowed as well.
排除标准
- •Subject has evidence of multiple ascites loculation
- •Ascites analysis with neutrophil count >250/µl within 24-hours prior to implant.
- •Subject has acute Urinary Tract Infection (UTI) within 24-hours of implantation assessed by urinalysis.
- •Subject has skin infection of the abdominal wall at the area of implantation.
- •Subject has a serum creatinine > 1.5 mg/dL Subject has
- •Subject has obstructive uropathy (bladder residual volume >100 mL, determined by catheterization or abdominal ultrasound) in case of Lower Urinary Tract Symptoms (LUTS) .
- •Existing bladder anomaly denying proper catheterization of the bladder.
- •Subject has active bleeding or thrombocytopenia < 45,000 X106/L.
- •Subject on long-term prophylactic anticoagulation
- •Subject is pregnant or a female of childbearing potential.
- •Patient has recurrent requirement for MRI
- •Subject is currently participating in an oncology trial which might be negatively affected by the alfapump as assessed by the treating physician
结局指标
主要结局
Monthly therapeutic paracentesis frequency up to 3 months
时间窗: 3 months post-implantation
Monthly therapeutic paracentesis frequency up to 3 months compared to the baseline therapeutic paracentesis frequency. The monthly therapeutic paracentesis frequency up to 3 months is defined as the average rate of therapeutic paracenteses during month 1, 2 and 3 post-implantation. Baseline therapeutic paracentesis frequency is defined as the average rate of therapeutic paracentesis in the 3 months prior to pump implantation.
次要结局
- Safety outcome- Incidence of device related infection(at 3-month, 6-month and 9-month follow-up)
- Safety outcome- Incidence of Procedure related events(At 1 month follow-up.)
- Safety outcome- Bladder metastasis: Freedom from metastatic bladder wall infiltration(at 6-month follow-up)
- Safety outcome- Worsening of renal function(at 3-month, 6-month and 9-month follow-up compared to baseline)
- Monthly therapeutic paracentesis frequency up to 6 months(6 months post-implantation)
- Safety outcome: free survival(Time (days) to first paracentesis after implantation through 270 days post implantation)
- Efficacy outcome- Assessment of changes in Quality of Life(at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline)
- Nutritional status outcome(at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline)
- Pump performance(at 1-month, 3-month, 6-month and 9-month follow-up)
- Pump performance outcome - pump survival(Time (days) from implantation until first exchange due to technical causes through study completion up to 270 days post-pump implantation)
- Pump performance outcome(throug study completion up to to 270 days post-pump implantation)
- Safety outcome - subject survival(Time (days) until exitus through study completion up to 270 days post-pump implantation)
- Safety outcome- Incidence of Device related events(at 3-month, 6-month and 9-month follow-up)
- Device failure(Through study completion up to 270 days post-pump implantation)