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ACTIVE NOT RECRUITING
NCT06210685
NA

The ACES Study for Aseptic Pleural Effusion

Sponsor: Pleural Dynamics, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2024-05-12

Completion Date

2025-12

Last Updated

2025-08-11

Healthy Volunteers

No

Interventions

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 (4)

Memorial Healthcare System

Hollywood, Florida, United States

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

University of North Carolina Pulmonary and Critical Care Medicine

Chapel Hill, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States