The ACES Study for Aseptic Pleural Effusion

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pleural Effusion
• Intervention / Treatment: Device: Automatic Continuous Effusion Shunt implantation

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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins School of Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Pulmonary and Critical Care Medicine
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACES Device; Implantation of the ACES device for treatment of aseptic pleural effusion	Device: 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.; Other Names: ACES Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint	Percentage change in pleural effusion volume via chest CT from baseline	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Rate of Adverse Events (serious and non-serious) including hospitalizations/visits	30 and 60 days
Pleurodesis	Rate of Pleurodesis	30 and 60 days
VAS Breathlessness Score	Change in VAS Breathlessness Score	30 and 60 days

Collaborators and Investigators

• Sponsor: Pleural Dynamics, Inc.
• Collaborators: Medical Metrics Diagnostics, Inc
• Investigators: Principal Investigator: Fabien Moldanado, MD, MSc, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2024
• Primary Completion (Actual): July 28, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: pleural effusion; malignant pleural effusion; IPC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: CL2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes