EmbolizationGPXNCT06453642
Evaluation of a Simple-Prep Controlled Embolic
A study testing GPX® Embolic Device in people with Embolization and Vascular Tumor, run by Fluidx Medical Technology, Inc. at 20 sites in 3 countries.
Trial summary
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 vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Embolization, Vascular Tumor, Renal Angiomyolipoma
- What is being tested?
- GPX® Embolic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 18 Nov 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years on the date of consent
- Expected post-procedural lifespan of at least 30 days, in the opinion of the investigator, to allow for participation in all follow-up visits
- Presents with need for peripheral embolization where there is a desire for distal vessel bed penetration including:
- Vascular tumors (e.g., renal angiomyolipoma, renal cell carcinoma, bone tumors, bleeding tumors, and other vascular tumors)
- Renal embolization
- Portal vein branches
- Informed consent granted by the patient or legally authorized representative
- Willing and able to comply with the protocol-specified procedures and assessments
Who cannot join
- Requires embolization for any of the following applications: a) Neurovasculature b) Coronary vasculature c) Hemorrhage due to trauma d) Non-tumoral focal/active bleeding sites (e.g., gastrointestinal tract, urinary tract, lung) e) Veins other than portal vein f) Aneurysms g) Endoleaks h) Vascular malformations i) Vessels for flow redistribution
- Has undergone an embolization procedure within 30 days prior to consent
- Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine)
- Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents)
- Known allergy or hypersensitivity to contrast media that cannot be adequately medicated
- Pregnant, planning to become pregnant during the study period, or breastfeeding
Show all 13Show fewer
- Unresolved systemic infection or localized infection in the targeted region
- Pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the investigator, would clinically confound the study primary endpoints
- Existing medical condition which, in the opinion of the investigator, may cause the subject to be intolerant of an occlusion procedure or non-compliant with the protocol or may confound the data interpretation
- Subject is participating in another device, drug, or procedure clinical investigation and has not completed the study treatment or the other investigation clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints)
- Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults) 12. Patients with drug or alcohol dependency (within 6 months prior to study entry) that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or with the interpretation of study results
- Intra-procedural exclusion criteria:
- 13. Presence of persistent, flow-limiting vasospasm that is not responsive to chemical or mechanical interventions 14. Presence of collateral pathways potentially endangering normal territories during embolization 15. Blood flow precludes safe delivery of embolic material (e.g., arteriovenous shunting or high, unpredictable flow exists) 16. Anatomy that precludes advancement of the delivery device to target vessel embolization site or delivery of embolic material 17. Dissection in the target vessel 18. The delivery device has already been used with an ionic contrast agent (e.g., Conray® (iothalamate meglumine injection USP 60%), Guerbet)
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States15 sites
Albany Medical Center
Albany, New York, 12208
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
University of North Carolina
Chapel Hill, North Carolina, 27514
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
University of Texas Southwestern
Dallas, Texas, 75390
MD Anderson Cancer Center - Interventional Radiology
Houston, Texas, 77030
Indiana University Hospital
Indianapolis, Indiana, 46202
University of California San Diego Altman Clinical and Translation Research Institute
La Jolla, California, 92037
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
Canada3 sites
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto General Hosptial
Toronto, Ontario, M5G 1Z5
Mount Sinai Hospital Toronto
Toronto, Ontario, M5G 2C4
New Zealand2 sites
Auckland City Hospital
Auckland
Christchurch Hospital
Christchurch, 4710
About this study
Official title: Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)
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 vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada.
Read the detailed description
The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study. Subjects will undergo distal embolization in the peripheral vasculature, including vascular tumors, renal embolizations, and portal vein branches, with the GPX® Embolic Device and will then be followed 30-days post-procedure.
- Conditions
- Embolization, Vascular Tumor, Renal Angiomyolipoma, Renal Cell Carcinoma, Bone Tumor, Portal Vein Embolization
- Being tested
- GPX® Embolic Device
- Keywords
- Embolization, Distal Embolization, Distal Vessel Penetration, Peripheral Vasculature
- Medical subject headings
- Vascular Neoplasms, Angiomyolipoma, Carcinoma, Renal Cell, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPX® Embolic DeviceDevice
Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches
| Study group | Role | What they receive |
|---|---|---|
| GPX® Embolic Device | Experimental | Not described Receives: Device: GPX® Embolic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major adverse events (MAEs)
MAEs are defined as:
- Nontarget embolization with ischemia in an unintended anatomical area
- Systemic allergic and/or toxic reaction to the GPX Embolic Device
- Catheter entrapment and/or breakage
- Culture-proven abscess in target organ/tissue
- Embolization-related death
Measured: Index procedure through 30-day follow-up
Single binomial proportion of successful delivery of the GPX Embolic Device to the target vessel embolization site(s)
Determined by the investigator at the time of enrollment
Measured: During procedure
Single binomial proportion of successful occlusion of flow immediately beyond the target vessel embolization site(s)
Determined by the core lab via comparison of the pre- and final post-embolization images
Measured: End of procedure
Secondary outcomes (3)
Occurrence of device-related adverse events (AE) through 30 days post-index procedure
Measured: 30-day follow-up
Occurrence of adjunctive embolization agent usage during the embolization procedure
Measured: End of procedure
Occurrence of catheter occlusion due to the GPX Embolic Material
Measured: End of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start18 Nov 2024
- Primary completionMay 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmbolizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluidx Medical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Michael Darcy, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453642
- Sponsor's protocol ID
- FLX-CL-5000
- Acronym
- GPX
- Status last verified
- Mar 2026
- First submitted
- 29 May 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)
- ClinicalTrials.gov ID
- NCT06453642
- Acronym / sponsor ID
- GPX / FLX-CL-5000
- Conditions
- Embolization, Vascular Tumor, Renal Angiomyolipoma, Renal Cell Carcinoma, Bone Tumor, Portal Vein Embolization
- Keywords
- Embolization, Distal Embolization, Distal Vessel Penetration, Peripheral Vasculature
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Fluidx Medical Technology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada.
Detailed description
The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study. Subjects will undergo distal embolization in the peripheral vasculature, including vascular tumors, renal embolizations, and portal vein branches, with the GPX® Embolic Device and will then be followed 30-days post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study.
| Arm | Type | Receives |
|---|---|---|
| GPX® Embolic Device | Experimental | Device: GPX® Embolic Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years on the date of consent
- Expected post-procedural lifespan of at least 30 days, in the opinion of the investigator, to allow for participation in all follow-up visits
- Presents with need for peripheral embolization where there is a desire for distal vessel bed penetration including:
- Informed consent granted by the patient or legally authorized representative
- Willing and able to comply with the protocol-specified procedures and assessments
Key exclusion criteria (13 listed)
- Requires embolization for any of the following applications: a) Neurovasculature b) Coronary vasculature c) Hemorrhage due to trauma d) Non-tumoral focal/active bleeding sites (e.g., gastrointestinal tract, urinary tract, lung) e) Veins other than portal vein f) Aneurysms g) Endoleaks h) Vascular malformations i) Vessels for flow redistribution
- Has undergone an embolization procedure within 30 days prior to consent
- Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine)
- Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents)
- Known allergy or hypersensitivity to contrast media that cannot be adequately medicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPX® Embolic DeviceTreatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches | Device | GPX® Embolic Device |
Primary outcome
Freedom from major adverse events (MAEs)
Time frame: Index procedure through 30-day follow-up
MAEs are defined as: * Nontarget embolization with ischemia in an unintended anatomical area * Systemic allergic and/or toxic reaction to the GPX Embolic Device * Catheter entrapment and/or breakage * Culture-proven abscess in target organ/tissue * Embolization-related death
Single binomial proportion of successful delivery of the GPX Embolic Device to the target vessel embolization site(s)
Time frame: During procedure
Determined by the investigator at the time of enrollment
Single binomial proportion of successful occlusion of flow immediately beyond the target vessel embolization site(s)
Time frame: End of procedure
Determined by the core lab via comparison of the pre- and final post-embolization images
3 secondary outcomes
Occurrence of device-related adverse events (AE) through 30 days post-index procedure
Time frame: 30-day follow-up
Occurrence of adjunctive embolization agent usage during the embolization procedure
Time frame: End of procedure
Occurrence of catheter occlusion due to the GPX Embolic Material
Time frame: End of procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Embolization
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Recruiting
Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)
Transurethral Resection of Prostate Syndrome, Prostate Hyperplasia
Not yet recruiting
Middle Meningeal Artery Embolization in Patients With Chronic Subdural Hematoma
Middle Meningeal Artery Embolization, Chronic Subdural Hematomas
RecruitingObservational study
Prospective Observational Study Of Geniculate Artery Embolization For Symptomatic Knee Osteoarthritis In A Cancer Population
Observational Study, Geniculate Artery
Not yet recruiting
Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization
Chronic Subdural Hematoma, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Darcy, MD principal investigator
Washington University School of Medicine
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPX® Embolic Device in people with Embolization and Vascular Tumor, run by Fluidx Medical Technology, Inc. at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major adverse events (MAEs) (time frame: Index procedure through 30-day follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.