The ACES Study for Aseptic Pleural Effusion

Pleural Dynamics

Status: Active, not recruiting

Conditions: Pleural Effusion

Treatments: Device: Automatic Continuous Effusion Shunt implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06210685

CL2301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

ACES Device

Experimental group

Description:

Implantation of the ACES device for treatment of aseptic pleural effusion

Treatment:

Device: Automatic Continuous Effusion Shunt implantation