Clinical trial · Interventional
The ACES Study for Aseptic Pleural Effusion
A Post-Market Study Evaluating Fluid Shunting Using the Automatic Continuous Effusion Management System (ACES™) in Patients With Symptomatic Aseptic Pleural Effusion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automatic Continuous Effusion Shunt implantation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ACES Device
- description
- Implantation of the ACES device for treatment of aseptic pleural effusion
- interventionNames
- Device: Automatic Continuous Effusion Shunt implantation
Primary outcomes (1)
- measure
- Primary Efficacy Endpoint
- timeFrame
- 30 days
- description
- Percentage change in pleural effusion volume via chest CT from baseline
Secondary outcomes (3)
- measure
- Adverse Events
- timeFrame
- 30 and 60 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
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