Pleural EffusionNCT06210685
The ACES Study for Aseptic Pleural Effusion
A study testing Automatic Continuous Effusion Shunt implantation in people with Pleural Effusion, run by Pleural Dynamics, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Automatic Continuous Effusion Shunt implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 May 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
University of North Carolina Pulmonary and Critical Care Medicine
Chapel Hill, North Carolina, 27599
Memorial Healthcare System
Hollywood, Florida, 33021
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: A Post-Market Study Evaluating Fluid Shunting Using the Automatic Continuous Effusion Management System (ACES™) in Patients With Symptomatic Aseptic Pleural Effusion
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.
Read the 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.
- Conditions
- Pleural Effusion
- Being tested
- Automatic Continuous Effusion Shunt implantation
- Keywords
- pleural effusion, malignant pleural effusion, IPC
- Medical subject headings
- Pleural Effusion, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic Continuous Effusion Shunt implantationDevice
Also called ACES Catheter
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.
| Study group | Role | What they receive |
|---|---|---|
| ACES Device | Experimental | Implantation of the ACES device for treatment of aseptic pleural effusion Receives: Device: Automatic Continuous Effusion Shunt implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
Percentage change in pleural effusion volume via chest CT from baseline
Measured: 30 days
Secondary outcomes (3)
Adverse Events
Rate of Adverse Events (serious and non-serious) including hospitalizations/visits
Measured: 30 and 60 days
Pleurodesis
Rate of Pleurodesis
Measured: 30 and 60 days
VAS Breathlessness Score
Change in VAS Breathlessness Score
Measured: 30 and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start12 May 2024
- Primary completion28 Jul 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pleural Dynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Metrics Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Fabien Moldanado, MD, MSc, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210685
- Sponsor's protocol ID
- CL2301
- Status last verified
- Aug 2025
- First submitted
- 8 Jan 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study Evaluating Fluid Shunting Using the Automatic Continuous Effusion Management System (ACES™) in Patients With Symptomatic Aseptic Pleural Effusion
- ClinicalTrials.gov ID
- NCT06210685
- Acronym / sponsor ID
- CL2301
- Conditions
- Pleural Effusion
- Keywords
- pleural effusion, malignant pleural effusion, IPC
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Pleural Dynamics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medical Metrics Diagnostics, Inc
- Study start
- 12 May 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACES Device | Experimental | Device: Automatic Continuous Effusion Shunt implantationImplantation of the ACES device for treatment of aseptic pleural effusion |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic Continuous Effusion Shunt implantationAlso: ACES CatheterThe 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. | Device | ACES Device |
Primary outcome
Primary Efficacy Endpoint
Time frame: 30 days
Percentage change in pleural effusion volume via chest CT from baseline
3 secondary outcomes
Adverse Events
Time frame: 30 and 60 days
Pleurodesis
Time frame: 30 and 60 days
VAS Breathlessness Score
Time frame: 30 and 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Pleural Effusion
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
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Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
UNC Pleural Fluid Registry
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Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien Moldanado, MD, MSc principal investigator
Vanderbilt University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic Continuous Effusion Shunt implantation in people with Pleural Effusion, run by Pleural Dynamics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.