The ACES Study for Aseptic Pleural Effusion

NCT06210685 | Active Not Recruiting FDA Device

• 1 other identifier: CL2301
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

Pleural Effusion

Keywords

pleural effusion; malignant pleural effusion; IPC

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint

  Percentage change in pleural effusion volume via chest CT from baseline

  30 days

Secondary Outcomes (3)

• Adverse Events

  30 and 60 days

• Pleurodesis

  30 and 60 days

• VAS Breathlessness Score

  30 and 60 days

Study Arms (1)

ACES Device

EXPERIMENTAL

Implantation of the ACES device for treatment of aseptic pleural effusion

Device: Automatic Continuous Effusion Shunt implantation

Interventions

Automatic Continuous Effusion Shunt implantation 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.

Also known as: ACES Catheter

ACES Device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated.
• Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
• Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.

You may not qualify if:

• Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated.
• Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
• Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.

Sponsors & Collaborators

• Pleural Dynamics, Inc.: lead
• Medical Metrics Diagnostics, Inc: collaborator

Study Sites (4)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21224, United States

Location

University of North Carolina Pulmonary and Critical Care Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pleural Effusion; Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Fabien Moldanado, MD, MSc

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: May 12, 2024
• Primary Completion: July 28, 2025
• Study Completion: December 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)