Shunt Implantation for Pleural Effusion

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

25 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Automatic Continuous Effusion Shunt for pleural effusion?

Research on similar treatments, like pleuro-peritoneal shunts, shows they can effectively manage pleural effusion by controlling fluid build-up around the lungs, providing relief from symptoms and reducing the need for repeated procedures. Studies indicate that these shunts can function well for at least 21 months with minimal complications. ^{1 2 3 4 5}

Is shunt implantation for pleural effusion generally safe in humans?

There is no specific safety data available for shunt implantation for pleural effusion, but shunt procedures in general, such as those for hydrocephalus, can have complications with a significant failure rate within the first year. ^{6 7 8 9 10}

How does the Automatic Continuous Effusion Shunt treatment differ from other treatments for pleural effusion?

The Automatic Continuous Effusion Shunt is unique because it continuously drains excess fluid from the pleural space (area around the lungs) into the peritoneal cavity (abdominal space) using a pump and one-way valves, offering an alternative to repeated needle withdrawals or chest tube placement. This method can be performed under local anesthesia and has shown to be effective with minimal complications, providing a long-term solution for managing pleural effusions. ^{1 2 5 11 12}

What is the purpose of this trial?

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.

Research Team

Fabien Moldanado, MD, MSc

Principal Investigator

Vanderbilt University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Pleural peritoneal shunting for benign and malignant pleural effusions. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of refractory, nonmalignant hydrothorax with a pleurovenous shunt. [2019]

4. Japan pubmed.ncbi.nlm.nih.gov

[Pleuro-peritoneal shunt in a patient with intractable pleural effusion after cardiac surgery]. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Beta-2-transferrin to detect cerebrospinal fluid pleural effusion: a case report. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[Analysis of 177 Cases of Adverse Events of CSF Flow Control Shunts Based on Spontaneous Response System]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events in contemporary continuous-flow left ventricular assist devices: A multi-institutional comparison shows significant differences. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. Germany pubmed.ncbi.nlm.nih.gov

'Possible shunt malfunction' pathway for paediatric hydrocephalus-a study of clinical outcomes and cost implications. [2021]

11. France pubmed.ncbi.nlm.nih.gov

[Pleuro-peritoneal Denver shunt in treatment of chronic pleurisy]. [2009]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Pleuroperitoneal shunt in recurrent pleural effusions. [2019]