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Device

Shunt Implantation for Pleural Effusion

N/A
Recruiting
Led By Fabien Moldanado, MD, MSc
Research Sponsored by Pleural Dynamics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 and 60 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will include patients with recurrent pleural effusion who need treatment. Patients will undergo various assessments before receiving the ACES implant. After the implant, patients will be monitored in the hospital and then

Who is the study for?
This trial is for patients with recurrent pleural effusion, which causes symptoms like shortness of breath and chest discomfort. Candidates must need a catheter implant as determined by their doctor, be able to attend follow-up visits, receive calls related to the study, and have an ECOG performance status between 0-3.
What is being tested?
The ACES Study tests the Automatic Continuous Effusion Shunt (ACES) implant in patients with recurring non-infectious fluid build-up in the chest. Participants will undergo baseline assessments before receiving the ACES implant and then track pain and breathing difficulty at home.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include pain at the implant site, infection risk from surgery or device presence, possible interference with lung function or discomfort due to shunt operation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My doctor recommends a catheter for my recurring lung fluid buildup.
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I have symptoms like shortness of breath or chest discomfort.
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I can care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 and 60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 and 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy Endpoint
Secondary study objectives
Adverse Events
Pleurodesis
VAS Breathlessness Score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ACES DeviceExperimental Treatment1 Intervention
Implantation of the ACES device for treatment of aseptic pleural effusion

Find a Location

Who is running the clinical trial?

Medical Metrics Diagnostics, IncIndustry Sponsor
13 Previous Clinical Trials
1,739 Total Patients Enrolled
Pleural Dynamics, Inc.Lead Sponsor
Fabien Moldanado, MD, MScPrincipal InvestigatorVanderbilt University
~10 spots leftby Jun 2025
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