ACTIVE_NOT_RECRUITING

The ACES Study for Aseptic Pleural Effusion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-05-12
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06210685

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated.
  2. 2. Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician.
  3. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
  4. 4. Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.
  1. 1. Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated.
  2. 2. Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician.
  3. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
  4. 4. Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.

Contacts and Locations

Principal Investigator

Fabien Moldanado, MD, MSc
PRINCIPAL_INVESTIGATOR
Vanderbilt University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Pleural Dynamics, Inc.

  • Fabien Moldanado, MD, MSc, PRINCIPAL_INVESTIGATOR, Vanderbilt University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-12
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-05-12
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • pleural effusion
  • malignant pleural effusion
  • IPC

Additional Relevant MeSH Terms

  • Pleural Effusion