A Post-Market Study Evaluating Fluid Shunting Using the Automatic Continuous Effusion Management System (ACES™) in Patients With Symptomatic Aseptic Pleural Effusion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
The study will enroll recurrent aseptic pleural effusion patients who are designated by their physician as needing treatment to control the fluid. Baseline assessment will include a history and physical, chest imaging and quality of life questionnaires.
After ACES implantation, patients will remain under hospital care for general observation as per standard-of-care before being discharged home with access to electronic diaries for tracking pain and dyspnea.
详细描述
Pleural Dynamics is the first company to provide a fully implantable automatic effusion shunt that is powered by normal breathing and is designed for continuous symptom relief, and does not require an extended hospital stay, a catheter external to the chest, or expensive drainage canisters."
The current standard of care, pleurodesis, is often painful, requires an extended hospital stay, and is often unsuccessful requiring additional procedures to manage the effusion1. While an alternate approach-indwelling pleural catheters-exists, it requires that the patient have a portion of the catheter to be external to the chest and requires frequent drainage into proprietary external canisters to relieve symptoms. Pleural Dynamics' patented ACES™ System addresses these shortcomings with its' one-piece, fully implanted system that can be placed during a short hospital stay. This technology is designed to use normal breathing motion to automatically pump pleural effusion fluid out of the chest to the abdomen for reabsorption by the body eliminating the need for an external catheter and frequent drainage, providing ongoing symptom relief.
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
- •Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated.
- •Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.
排除标准
- •Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated.
- •Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: 30 days
Percentage change in pleural effusion volume via chest CT from baseline
次要结局
- Adverse Events(30 and 60 days)
- Pleurodesis(30 and 60 days)
- VAS Breathlessness Score(30 and 60 days)