Shunt Implantation for Pleural Effusion

Not currently recruiting at 3 trial locations

Overseen By Sharon McFadden, DVM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pleural Dynamics, Inc.

Disqualifiers: Recurrent pleural effusion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Short hospital stay

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Automatic Continuous Effusion Shunt (ACES) for individuals with recurrent pleural effusion, a condition where fluid accumulates around the lungs, causing shortness of breath and chest discomfort. The trial aims to determine if ACES can effectively control fluid buildup and improve patients' quality of life. It suits those with ongoing pleural effusion who require a catheter and experience symptoms like difficulty breathing or chest discomfort. After receiving the device, participants will stay in the hospital for observation and use electronic diaries to track their symptoms at home. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ACES device is safe for treating pleural effusion?

Research has shown that the Automatic Continuous Effusion Shunt (ACES) is generally safe and well-tolerated by patients with recurring fluid build-up in the chest. Studies have found that the ACES device effectively reduces this fluid without causing serious safety problems. Patients using the shunt did not experience major side effects related to the device. This evidence suggests that the treatment is safe for people based on current data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for pleural effusion, which often involve repeated needle drainage or surgical interventions like pleurodesis, the Automatic Continuous Effusion Shunt (ACES) device offers a more continuous and less invasive approach. This device works by automatically draining excess fluid from the pleural space, potentially reducing the need for frequent hospital visits and invasive procedures. Researchers are excited about the ACES device because it promises to improve patient comfort and quality of life by providing a more consistent and autonomous management of pleural effusion.

What evidence suggests that the ACES device is effective for treating pleural effusion?

Research has shown that the Automatic Continuous Effusion Shunt (ACES) device, which participants in this trial will receive, could help treat recurrent pleural effusion, a condition where fluid accumulates around the lungs. One study found that the ACES device significantly reduced this fluid buildup. Patients using the device experienced relief from symptoms such as shortness of breath and discomfort. The device continuously drains the fluid, offering a potential long-term solution. Early results suggest that this method is both safe and effective for managing the condition. ^{1 3 4 5 6}

Who Is on the Research Team?

Fabien Moldanado, MD, MSc

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My doctor recommends a catheter for my recurring lung fluid buildup.

I have symptoms like shortness of breath or chest discomfort.

I am willing and able to follow all study requirements, including visits and calls.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of the ACES device for treatment of aseptic pleural effusion

Short hospital stay

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and pleurodesis rate

60 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Automatic Continuous Effusion Shunt

Trial Overview 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.

How Is the Trial Designed?

Group I: ACES Device Experimental Treatment 1 Intervention

Implantation of the ACES device for treatment of aseptic pleural effusion

Who Is Running the Clinical Trial?

Pleural Dynamics, Inc.

Lead Sponsor

Trials

1

Recruited

30+

Medical Metrics Diagnostics, Inc

Industry Sponsor

Trials

14

Recruited

1,800+

Published Research Related to This Trial

The use of a pleuraperitoneal shunt in a 70-year-old patient with chronic pleurisy resulted in significant symptom improvement and no local complications after 13 months of follow-up, indicating its safety and efficacy for managing resistant pleural effusion.

This mini-invasive procedure, which involves a self-controlled pump and has shown a reduction in hospital stay length, presents a clear economic advantage, especially in cases of malignant pleurisy and chylous pleurisy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pleuro-peritoneal Denver shunt in treatment of chronic pleurisy]. Boudard, C., Gamondes, JP., Mornex, JF., et al.[2009]

In a 7-month audit of a 'possible shunt malfunction' pathway for children with hydrocephalus, only 16% of 81 attendances resulted in surgical intervention, indicating that most cases did not require immediate neurosurgical management.

The total cost for the pathway was significant, amounting to over £62,000, with inpatient stays accounting for nearly half of the expenses, highlighting the financial burden of managing shunt complications in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Possible shunt malfunction' pathway for paediatric hydrocephalus-a study of clinical outcomes and cost implications. Tong, L., Higgins, L., Sivakumar, G., et al.[2021]

The pleuro-peritoneal shunt is an effective device for managing recurrent pleural effusions by using a pump and one-way valves to prevent fluid build-up around the lungs, offering a less invasive option compared to repeated needle withdrawals or chest tube placements.

Post-operative care is crucial for patients with the shunt, ensuring proper function and minimizing complications, which highlights the importance of monitoring after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the pleuro-peritoneal shunt. McCall, E.[2017]

Pleural peritoneal shunting is an effective new technique for treating patients with symptomatic pleural effusion that does not respond to standard treatments, showing promising results with simple insertion under local anesthesia.

The procedure has demonstrated satisfactory function with minimal morbidity for at least 21 months, and any obstructed shunts can be easily remedied, with no noted adverse long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pleural peritoneal shunting for benign and malignant pleural effusions. Cimochowski, GE., Joyner, LR.[2016]

The Denver peritoneovenous shunt was successfully used in 3 patients with intractable recurrent pleural effusions, effectively controlling the condition in all cases.

This method allows for the easy diversion of pleural fluid into the peritoneal cavity, where it can be reabsorbed, and can be performed under either local or general anesthesia, making it a flexible treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pleuroperitoneal shunt in recurrent pleural effusions. Hussain, SA.[2019]

A 45-year-old man with severe mitral valve regurgitation and atrial fibrillation underwent successful mitral valve plasty and Maze procedure, leading to a satisfactory postoperative recovery.

Despite initial recovery, he developed significant left pleural effusion, which was effectively managed with a pleuro-peritoneal shunt, resulting in relief from dyspnea and no recurrence of effusion after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pleuro-peritoneal shunt in a patient with intractable pleural effusion after cardiac surgery]. Tsuji, M., Yamazaki, T.[2014]

In a study of 734 patients implanted with continuous-flow left ventricular assist devices (LVADs), the HeartWare HVAD was associated with a significantly higher risk of stroke compared to the HeartMate II (HR: 1.8), indicating a safety concern for patients using this device.

Overall mortality rates were similar between the two devices (7.3% for HMII and 7.5% for HVAD), but the analysis revealed that while gastrointestinal bleeding and infections were comparable, the HVAD showed a concerning trend of increased stroke risk over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in contemporary continuous-flow left ventricular assist devices: A multi-institutional comparison shows significant differences. Stulak, JM., Davis, ME., Haglund, N., et al.[2015]

A pleurovenous shunt was successfully used to manage intractable symptomatic hydrothorax caused by hepatic ascites after traditional treatments failed.

After one year of follow-up, the pleurovenous shunt effectively controlled the pleural effusion and remained patent, demonstrating its long-term efficacy and safety in this case.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of refractory, nonmalignant hydrothorax with a pleurovenous shunt. Park, SZ., Shrager, JB., Allen, MS., et al.[2019]

A 14-month-old boy developed a large pleural effusion and ascites two and a half months after receiving a ventriculoperitoneal shunt for hydrocephalus, indicating a rare but serious complication.

Testing pleural fluid for beta-2-transferrin can effectively diagnose cerebrospinal fluid hydrothorax, and in this case, externalizing the shunt led to the resolution of both the pleural effusion and ascites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-2-transferrin to detect cerebrospinal fluid pleural effusion: a case report. Smith, JC., Cohen, E.[2021]

A new framework for monitoring adverse events (AEs) in pregnancy trials has been developed, which includes specific definitions and severity grading for both maternal and fetal AEs, enhancing safety assessments for drugs and interventions.

The framework was created through a comprehensive literature review and consensus from an international group of experts, resulting in 12 maternal and 19 fetal AE definitions that can be systematically applied in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. Spencer, RN., Hecher, K., Norman, G., et al.[2022]

A retrospective analysis of 177 adverse event reports related to CSF flow control shunts revealed that 170 cases (96%) were associated with complications, primarily ventricular dilatation (21.2%) and infection (19.4%).

The study highlights the need for improved monitoring and safety measures to minimize adverse events linked to CSF flow control shunts, which may be influenced by product quality, surgical techniques, and patient conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of 177 Cases of Adverse Events of CSF Flow Control Shunts Based on Spontaneous Response System]. Zhao, Y., Shi, C., Huang, H., et al.[2018]

The article highlights the challenges medical device companies face in deciding whether to report adverse events related to device implants to regulatory authorities.

It discusses UK vigilance guidance documents that provide a framework to help manufacturers make informed decisions about reporting, which can enhance safety and accountability in the medical device industry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dilemma of reporting device-related adverse events. Donawa, M.[2016]

Citations

1. massdevice.com massdevice.com/pleural-dynamics-positive-data-effusion-shunt/

Pleural Dynamics reports positive data for automatic ... Pleural Dynamics today announced positive results from a prospective, multicenter study evaluating its ACES device.

2. pleuraldynamics.com pleuraldynamics.com/post/the-aces-study-for-aseptic-pleural-effusions

The ACES Study for Aseptic Pleural Effusions In this prospective, multi-center, single-arm study, 25 patients experiencing recurrent symptomatic pleural effusions at four U.S. centers ...

3. finance.yahoo.com finance.yahoo.com/news/study-demonstrates-significant-reduction-pleural-140000741.html

Study Demonstrates Significant Reduction in Pleural ... The ACES study (NCT06210685) evaluated the safety, feasibility, and efficacy of the fully internalized ACES pleuroperitoneal shunt in patients ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K231096.pdf

August 18, 2023 Pleural Dynamics, Inc. Joseph Ostendorf ... The ACES System is an implanted pleural-peritoneal shunt system intended to palliate symptoms of recurrent pleural effusion, an accumulation of ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/pleural-dynamics-treats-first-patient-with-pleural-effusion-device/

Pleural Dynamics treats first patient with pleural effusion ... The clinical trial will treat 25 patients who have experienced recurrent symptomatic pleural effusion with the ACES system.

6. morningstar.com morningstar.com/news/business-wire/20251028420741/study-demonstrates-significant-reduction-in-pleural-effusion-volume-using-pleural-dynamics-aces-fully-implantable-system

Study Demonstrates Significant Reduction in Pleural ... The ACES study (NCT06210685) evaluated the safety, feasibility, and efficacy of the fully internalized ACES pleuroperitoneal shunt in patients ...