GPX® Embolic Device for Embolism

(GPX Trial)

Recruiting at 20 trial locations

Overseen By Michelle Doyle, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fluidx Medical Technology, Inc.

Disqualifiers: Pregnancy, Infections, Drug dependency, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During procedure

114 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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

I have given my permission for treatment or my legal representative has.

My doctor believes I will live more than 30 days after my procedure.

I have a tumor that is related to the blood vessels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo distal embolization in the peripheral vasculature using the GPX® Embolic Device

During procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• GPX® Embolic Device

Trial Overview The GPX® Embolic Device is being tested for its safety and effectiveness in blocking blood vessels that feed tumors. The study will involve up to 114 participants across sites in the USA, New Zealand, and Canada.

How Is the Trial Designed?

Group I: GPX® Embolic Device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Fluidx Medical Technology, Inc.

Lead Sponsor

Trials

1

Recruited

110+

Bright Research Partners

Industry Sponsor

Trials

18

Recruited

2,700+

Published Research Related to This Trial

In a case study of a 73-year-old man with a right middle cerebral artery occlusion, early detection of reocclusion was achieved using transcranial Doppler monitoring after endovascular clot aspiration, highlighting the importance of continuous monitoring in stroke management.

The administration of the GPIIb-IIIa antagonist abciximab under ultrasound monitoring led to successful recanalization of distal occlusions, resulting in significant clinical improvement and no hemorrhagic complications, suggesting that this approach may enhance outcomes in similar cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial reocclusion and persistent distal occlusion after thrombus aspiration. Zhao, L., Rubiera, M., Harrigan, MR., et al.[2012]

Platelet GP IIb/IIIa receptor antagonists (GPAs) have been shown to effectively reduce ischemic complications in over 33,000 patients across 11 large trials, particularly during high-risk coronary interventions and in conditions like myocardial infarction and unstable angina.

These medications, including abciximab, eptifibatide, and tirofiban, are generally well tolerated and safe when used alongside other antithrombotics, as long as platelet counts are monitored and their use is carefully managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current knowledge of the platelet glycoprotein IIb/IIIa receptor antagonists for the treatment of coronary artery disease. Berkowitz, SD.[2018]

The small-molecule tracer 18F-GP1 shows high affinity for GPIIb/IIIa receptors, which are crucial for platelet aggregation, making it a promising tool for PET imaging of thrombi in various thromboembolic diseases.

In preclinical studies with cynomolgus monkeys, 18F-GP1 demonstrated rapid blood clearance and a high clot-to-blood ratio, allowing for effective detection of small thrombi and emboli, and it is now being evaluated in human clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-GP1, a Novel PET Tracer Designed for High-Sensitivity, Low-Background Detection of Thrombi. Lohrke, J., Siebeneicher, H., Berger, M., et al.[2018]

In a study of 1,392 octogenarians undergoing percutaneous coronary intervention (PCI), the use of glycoprotein IIb/IIIa receptor inhibitors (GPI) was linked to a higher incidence of bleeding complications, but did not significantly increase the need for blood transfusions or the risk of intracranial hemorrhage.

Despite being associated with longer hospital stays, GPI treatment in octogenarians did not independently predict mortality, suggesting that while there are risks, the overall safety profile remains acceptable for this age group undergoing PCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous coronary interventions in octogenarians. glycoprotein IIb/IIIa receptor inhibitors' safety profile. Sadeghi, HM., Grines, CL., Chandra, HR., et al.[2019]

In the CHAMPION PHOENIX trial, only 3.5% of the 10,942 patients required bailout glycoprotein IIb/IIIa inhibitors (GPI) for thrombotic complications, but those who did faced significantly higher risks of serious outcomes, including death and myocardial infarction, with a 19.2% incidence compared to 4.8% in non-GPI patients.

Patients receiving GPI also had a higher rate of severe or moderate bleeding (2.6% vs 0.4%), indicating that while GPI can be used in emergencies, it may lead to increased complications, suggesting that preventing thrombotic issues during procedures is a better strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of patients requiring bailout use of glycoprotein IIb/IIIa inhibitors for thrombotic complications of percutaneous coronary intervention: An analysis from the CHAMPION PHOENIX trial. Abtan, J., Ducrocq, G., Steg, PG., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37931844/

A First-in-Human Trial of a New Aqueous Ionic Liquid ... The results of this first-in-human, early feasibility study demonstrate that the GPX Embolic Device may provide safe and effective embolization for arterial or

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06453642?tab=table

Evaluation of a Simple-Prep Controlled Embolic (GPX) The objective of this study is to evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal ...

3. kidneycancer.org kidneycancer.org/trial/evaluation-of-a-simple-prep-controlled-embolic/

Evaluation of a Simple-Prep Controlled Embolic The objective of this study is to evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal ...

4. jvir.org jvir.org/article/S1051-0443(22)01512-3/fulltext

Abstract No. 43 Final Results of the GPX Embolic Device ... The results of this FIH trial demonstrate that the GPX Embolic Device may provide safe and effective embolization for arterial or venous applications where deep ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9885798/

Material characterization of GPX®: A versatile in situ ... GPX is a versatile liquid embolic platform that can be formulated with a wide range of viscosities injectable at clinically practical flow rates.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1051044323007972

A First-in-Human Trial of a New Aqueous Ionic Liquid ... The results of this first-in-human, early feasibility study demonstrate that the GPX Embolic Device may provide safe and effective embolization for arterial or ...

7. fluidxmedical.com fluidxmedical.com/gpx

GPX Embolic Device The GPX Embolic Device is an innovative deep, distally penetrating peripheral embolic ideal for oncology and other devascularization uses.