Clinical trial NCT06210685: The ACES Study for Aseptic Pleural Effusion
Official title: A Post-Market Study Evaluating Fluid Shunting Using the Automatic Continuous Effusion Management System (ACES™) in Patients with Symptomatic Aseptic Pleural Effusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pleural Effusion
Keywords: pleural effusion
malignant pleural effusion
IPC
Lead sponsor: Pleural Dynamics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medical Metrics Diagnostics, Inc
First posted: 2024-01-18
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 30 and 60 days
measure: Pleurodesis
timeFrame: 30 and 60 days
measure: VAS Breathlessness Score
timeFrame: 30 and 60 days
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Chapel Hill
country: United States
facility: University of North Carolina Pulmonary and Critical Care Medicine
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Fabien Moldanado, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: