The ACES Study for Aseptic Pleural Effusion

Description

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.

Conditions

Pleural Effusion

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Study Overview

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Study Details

Study overview

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.

A Post-Market Study Evaluating Fluid Shunting Using the Automatic Continuous Effusion Management System (ACES™) in Patients with Symptomatic Aseptic Pleural Effusion

The ACES Study for Aseptic Pleural Effusion

Condition
Pleural Effusion
Intervention / Treatment

-

Contacts and Locations

Hollywood

Memorial Healthcare System, Hollywood, Florida, United States, 33021

Baltimore

Johns Hopkins School of Medicine, Baltimore, Maryland, United States, 21224

Chapel Hill

University of North Carolina Pulmonary and Critical Care Medicine, Chapel Hill, North Carolina, United States, 27599

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pleural Dynamics, Inc.,

Fabien Moldanado, MD, MSc, PRINCIPAL_INVESTIGATOR, Vanderbilt University

Study Record Dates

2025-12