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The ACES Study for Aseptic Pleural Effusion
Sponsor: Pleural Dynamics, Inc.
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.
Official title: A Post-Market Study Evaluating Fluid Shunting Using the Automatic Continuous Effusion Management System (ACES™) in Patients With Symptomatic Aseptic Pleural Effusion
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2024-05-12
Completion Date
2025-12
Last Updated
2025-08-11
Healthy Volunteers
No
Conditions
Interventions
Automatic 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.
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