Gravity vs. Vacuum Drainage Systems for Pleural Effusion
(NEWTON Trial)
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 Gravity-Based IPC, Indwelling Tunneled Pleural Catheter (IPC), PleurX Catheter, Vacuum-Based IPC, Indwelling Tunneled Pleural Catheter (IPC), PleurX Catheter for pleural effusion?
Tunneled, indwelling pleural catheters (IPCs) have been shown to be effective in managing malignant pleural effusions, allowing for fluid drainage and potential pleurodesis (a procedure to stick the lung to the chest wall to prevent fluid buildup). Although the study on silver nitrate-coated IPCs did not show improved effectiveness over standard IPCs, standard IPCs are still considered effective for managing pleural effusions.12345
Is the use of indwelling pleural catheters (IPCs) generally safe for humans?
Indwelling pleural catheters (IPCs) are generally considered safe for managing pleural effusions, though complications like infection, air leaks, and valve malfunctions can occur. These complications are usually manageable, and IPCs are often preferred over other treatments like talc pleurodesis due to their safety profile.678910
How is the treatment with Gravity-Based IPC and Vacuum-Based IPC different from other treatments for pleural effusion?
The Gravity-Based IPC and Vacuum-Based IPC treatments use indwelling pleural catheters (IPCs) to drain fluid from the chest, offering a less invasive option compared to traditional methods like chemical pleurodesis, which involves using chemicals to stick the lung to the chest wall. IPCs can be managed at home, reducing hospital stays and allowing patients more comfort and flexibility.67111213
What is the purpose of this trial?
Malignant pleural effusion remains a debilitating complication of end stage cancer, which can be greatly improved by the introduction of the indwelling tunneled pleural catheter (IPC). However, there is no standard of care regarding drainage and limited data on the utility of different drainage techniques. In addition, many patients develop discomfort and chest pain during drainage. The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes.
Research Team
Lonny Yarmus, DO
Principal Investigator
Johns Hopkins University
Eligibility Criteria
This trial is for adults over 17 with malignant pleural effusion, who've felt better after draining fluid from the chest. They must be able to safely have a catheter inserted and manage its care. Excluded are those with certain conditions like bleeding disorders, recent chest surgeries or trauma, very short life expectancy, or current infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo placement of a pleural catheter and are randomized into suction drainage (active) or gravity drainage (passive) arms
Follow-up
Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and pain monitoring
Treatment Details
Interventions
- Gravity-Based IPC
- Vacuum-Based IPC
Gravity-Based IPC is already approved in United States, European Union, Canada for the following indications:
- Malignant pleural effusion
- Malignant pleural effusion
- Malignant pleural effusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Rocket Medical plc
Collaborator
Swedish Medical Center
Collaborator
Medical University of South Carolina
Collaborator
University of Oxford
Collaborator
Vanderbilt University Medical Center
Collaborator
Northwest Community Healthcare
Collaborator