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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06210685.
Locations matching your search criteria
United States
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer CenterStatus: Active
Name Not Available
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.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationPleural Dynamics, Inc.
