NCT01952327终止不适用
Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.
Sequana Medical N.V.2 个研究点 分布在 2 个国家目标入组 2 人开始时间: 2014年5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
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Incidence and severity of device, procedure and therapy related serious adverse events.
研究概览
简要总结
This is a research study examining the safety of a new, automated pump for the drainage of fluid in the chest cavity which is caused by cancer (also known as malignant pleural effusion, or MPE). The purpose of the trial is to assess whether the new pleurapump device is safe and effective in the management of patients with MPE. The study will try to identify what kind of problems may arise from using the device, how often they happen, and how severe they are if they occur.
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
- •> 18 years of age
- •Recurrent pleural effusion due malignancy Malignant pleural effusions are defined as either Fluid in the context of histocytologically confirmed pleural malignancy, or pleural fluid in the context of histocytologically confirmed malignancy elsewhere, with no other clear cause for the effusion.
- •1 or more therapeutic procedures for pleural fluid drainage prior to enrolment.
- •Written informed consent
- •Ability to comply with study procedures and ability to operate the device
- •Expected survival of more than 3 months after device insertion
排除标准
- •Haemothorax
- •Purulent pleural effusion
- •Significant pleural fluid septation or loculation on thoracic ultrasound or cross-sectional imaging
- •Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device.
- •Pregnant females or females anticipating pregnancy during study period.
- •Patients currently enrolled in another interventional clinical study
- •Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to cardiac pacemaker or cardioverter defibrillator.
- •Major comorbidity which, in the opinion of the principal investigator, is likely to significantly decrease life expectancy, increase anaesthetic risk, or lead to device removal (e.g. moderate to severe congestive heart failure, significant valvular heart disease, persistent immunosuppression, etc.)
- •Other contraindication to general anaesthesia
- •Other contraindication to procedure (e.g. uncorrectable bleeding diathesis, infection or malignant involvement over proposed insertion site)
- •Significant renal impairment, as determined by the principal investigator
研究组 & 干预措施
plueurapump
Other
Implantation of pleurapump system
干预措施: The pleurapump system (Device)
结局指标
主要结局
Incidence and severity of device, procedure and therapy related serious adverse events.
时间窗: 3 months
Incidence and severity of device, procedure and therapy related serious adverse events.
次要结局
- Efficacy of treatment as assessed by the volume of fluid removed(3 months)
- Subjective thoracic pain on the side of the intervention(3 months)
- Costs of health resource use(3 months)
- Quality of life(3 months)
- Need for further intervention to manage pleural fluid (on the side of the intervention)(3 months)
- Subjective abdominal pain(3 months)
- Subjective breathlessness(3 months)
研究者
研究点 (2)
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