The ACES Study for Aseptic Pleural Effusion

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210685
• Other study ID #: CL2301
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Pleural Dynamics, Inc.
• Contact: Martin Mayse, MD
• Phone: 314.518.1786
• Email: research[@]pleuraldynamics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Device:
• Automatic Continuous Effusion Shunt implantation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pleural Dynamics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint	Percentage change in pleural effusion volume via chest CT from baseline	30 days
Secondary	Adverse Events	Rate of Adverse Events (serious and non-serious) including hospitalizations/visits	30 and 60 days
Secondary	Pleurodesis	Rate of Pleurodesis	30 and 60 days
Secondary	VAS Breathlessness Score	Change in VAS Breathlessness Score	30 and 60 days