GPX® Embolic Device for Embolism
(GPX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the GPX® Embolic Device to assess its safety and effectiveness in blocking blood flow in small blood vessels for specific conditions. The device targets conditions such as vascular tumors or issues requiring blockage in small vessels around the kidneys or certain veins. The trial seeks participants who need this type of treatment and can attend follow-up visits for at least 30 days after the procedure. Those with conditions requiring embolization (a procedure to block blood flow) in areas like vascular tumors or renal vessels might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.
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 team or your doctor.
What prior data suggests that the GPX® Embolic Device is safe for embolization?
Research has shown that the GPX® Embolic Device appears promising for safe use in people. Early results from a first-in-human study suggested that this device might be safe for embolization, a procedure used to block blood vessels. The study found no major safety problems, which is a positive sign. However, this remains a new treatment, and further research will help confirm its safety. For those considering joining a trial using this device, these early results are encouraging but not yet definitive.12345
Why are researchers excited about this trial?
The GPX® Embolic Device is unique because it introduces a novel approach to treating embolism by using an advanced embolic material that can be precisely delivered to block blood flow in targeted areas. Unlike traditional embolic agents that might require complex preparation or have limited control, the GPX® device allows for easy in-situ mixing and immediate use, offering enhanced precision and control. Researchers are excited about this treatment because it promises improved safety and effectiveness in managing embolism compared to existing options like coils or liquid embolics, potentially leading to better patient outcomes.
What evidence suggests that the GPX® Embolic Device is effective for embolization?
Research has shown that the GPX® Embolic Device, which participants in this trial will receive, might effectively block blood vessels in both arteries and veins. Early studies indicated that this device can safely stop blood flow in specific areas. The GPX device is designed to be flexible, allowing it to change thickness to fit different situations in the body. This flexibility makes it easy to use in various medical contexts. Overall, these studies suggest that GPX can effectively stop blood flow where needed.12467
Who Is on the Research Team?
Michael Darcy, MD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults over 18 with certain vascular tumors like kidney cancer or bone tumors, who need a procedure to block blood flow to these areas. They must expect to live at least another month and be able to follow the study's procedures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects undergo distal embolization in the peripheral vasculature using the GPX® Embolic Device
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GPX® Embolic Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fluidx Medical Technology, Inc.
Lead Sponsor
Bright Research Partners
Industry Sponsor