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The ACES Study for Aseptic Pleural Effusion

NCT06210685 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medical Metrics Diagnostics, Inc

    collaborator INDUSTRY

  • Pleural Dynamics, Inc.

    lead INDUSTRY

Principal Investigators

  • Fabien Moldanado, MD, MSc · Vanderbilt University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-12
Primary Completion
2025-07-28
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06210685 on ClinicalTrials.gov