Pleural Effusion
Conditions
Keywords
pleural effusion, malignant pleural effusion, IPC
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAutomatic Continuous Effusion Shunt implantation
The catheter pump chamber is placed with part of the chamber between adjacent ribs and part of the chamber under the skin and external to the ribs. The pump chamber is used to transfer pleural fluid into the peritoneal cavity.
Sponsors
Medical Metrics Diagnostics, Inc
Pleural Dynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated. 2. Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 4. Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.
Exclusion criteria
1. Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated. 2. Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 4. Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint | 30 days | Percentage change in pleural effusion volume via chest CT from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 30 and 60 days | Rate of Adverse Events (serious and non-serious) including hospitalizations/visits |
| Pleurodesis | 30 and 60 days | Rate of Pleurodesis |
| VAS Breathlessness Score | 30 and 60 days | Change in VAS Breathlessness Score |
Countries
United States
Outcome results
None listed