The ACES Study for Aseptic Pleural Effusion
- Conditions
- Pleural Effusion
- Interventions
- Device: Automatic Continuous Effusion Shunt implantation
- Registration Number
- NCT06210685
- Lead Sponsor
- Pleural Dynamics, Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- 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 0-3.
- Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.
- 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 0-3.
- Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ACES Device Automatic Continuous Effusion Shunt implantation Implantation of the ACES device for treatment of aseptic pleural effusion
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoint 30 days Percentage change in pleural effusion volume via chest CT from baseline
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Johns Hopkins School of Medicine
🇺🇸Baltimore, Maryland, United States
University of North Carolina Pulmonary and Critical Care Medicine
🇺🇸Chapel Hill, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States