The ACES Study for Aseptic Pleural Effusion

NCT ID: NCT06210685

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-12
• Study Completion Date: 2025-12-31

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 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.

Conditions

Pleural Effusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACES Device

Implantation of the ACES device for treatment of aseptic pleural effusion

Group Type: EXPERIMENTAL

Automatic Continuous Effusion Shunt implantation

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Other Intervention Names

ACES Catheter

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Metrics Diagnostics, Inc

INDUSTRY

Sponsor Role: collaborator

Pleural Dynamics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabien Moldanado, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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

Countries

United States

Other Identifiers

CL2301

Identifier Type: -

Identifier Source: org_study_id