New device aims to starve tumors by cutting off their blood supply
NCT ID NCT06453642
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device called GPX that blocks blood flow to tumors or other targeted areas. About 114 adults with conditions like kidney tumors or bone tumors will receive the treatment. The goal is to see if the device is safe and works well at reaching and blocking small blood vessels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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114 people
The number who actually took part.
- Started
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Nov 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years on the date of consent 2. Expected post-procedural lifespan of at least 30 days, in the opinion of the investigator, to allow for participation in all follow-up visits 3. 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 4. Informed consent granted by the patient or legally authorized representative 5. Willing and able to comply with the protocol-specified procedures and assessments Exclusion Criteria: 1. 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 2. Has undergone an embolization procedure within 30 days prior to consent 3. Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine) 4. Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents) 5. Known allergy or hypersensitivity to contrast media that cannot be adequately medicated 6. Pregnant, planning to become pregnant during the study period, or breastfeeding 7. Unresolved systemic infection or localized infection in the targeted region 8. 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 9. 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 10. 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) 11. 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Albany Medical Center
Albany, New York, 12208, United States
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Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
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Auckland City Hospital
Auckland, New Zealand
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Christchurch Hospital
Christchurch, 4710, New Zealand
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Indiana University Hospital
Indianapolis, Indiana, 46202, United States
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MD Anderson Cancer Center - Interventional Radiology
Houston, Texas, 77030, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Mount Sinai
New York, New York, 10029, United States
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Mount Sinai Hospital Toronto
Toronto, Ontario, M5G 2C4, Canada
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Northwestern University
Chicago, Illinois, 60611, United States
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St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
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Toronto General Hosptial
Toronto, Ontario, M5G 1Z5, Canada
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University of California San Diego Altman Clinical and Translation Research Institute
La Jolla, California, 92037, United States
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
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University of North Carolina
Chapel Hill, North Carolina, 27514, United States
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University of Texas Southwestern
Dallas, Texas, 75390, United States
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University of Virginia Health System
Charlottesville, Virginia, 22908, United States
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Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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