Implantable device for treating recurrent pleural effusion

A Post-Market Study Evaluating Fluid Shunting Using the Automatic Continuous Effusion Management System (ACES™) in Patients with Symptomatic Aseptic Pleural Effusion

This study is testing a new implantable device that helps people with recurring fluid buildup in their chest by automatically pumping the fluid away to see if it works better than current treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Pleural Dynamics, Inc. (Industry-sponsored)
• Locations: 4 sites (Hollywood, Florida and 3 other locations)
• Trial ID: NCT06210685 on ClinicalTrials.gov

What this trial studies

This study focuses on patients with recurrent aseptic pleural effusion who require treatment to manage fluid accumulation. Participants will undergo implantation of the ACES™ System, a fully implantable automatic effusion shunt that utilizes normal breathing to continuously pump fluid from the chest to the abdomen. Patients will be monitored in the hospital post-implantation and will use electronic diaries to track their symptoms, including pain and dyspnea. The study aims to provide a less invasive and more effective alternative to current treatments like pleurodesis and indwelling pleural catheters.

Who should consider this trial

Good fit: Ideal candidates are patients experiencing recurrent pleural effusion who have been deemed by their physician to require catheter implantation.

Not a fit: Patients who do not have recurrent pleural effusion or those for whom catheter implantation is not indicated may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve symptom relief and quality of life for patients with recurrent pleural effusion.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving management of pleural effusions, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Hollywood, Florida and 3 other locations

• Memorial Healthcare System — Hollywood, Florida, United States (Recruiting)
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
• University of North Carolina Pulmonary and Critical Care Medicine — Chapel Hill, North Carolina, United States (Recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Fabien Moldanado, MD, MSc — Vanderbilt University
• Study coordinator: Martin Mayse, MD

Conditions Pleural Effusion; pleural effusion; malignant pleural effusion; IPC