Status:
ACTIVE_NOT_RECRUITING
The ACES Study for Aseptic Pleural Effusion
Lead Sponsor:
Pleural Dynamics, Inc.
Collaborating Sponsors:
Medical Metrics Diagnostics, Inc
Conditions:
Pleural Effusion
Eligibility:
All Genders
21+ years
Phase:
NA
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 physic...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06210685
Start Date
May 12 2024
End Date
December 1 2025
Last Update
August 11 2025
Active Locations (4)
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1
Memorial Healthcare System
Hollywood, Florida, United States, 33021
2
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21224
3
University of North Carolina Pulmonary and Critical Care Medicine
Chapel Hill, North Carolina, United States, 27599
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232