Use of the GPX Embolic Device in Patients Requiring Embolization
A Feasibility Study of the GPX Embolic Device
Fluidx Medical Technology, LLC
20 participants
Nov 17, 2020
Interventional
Conditions
Summary
This study is a single-arm, open label, non-randomized, prospective, first in human (FIH) feasibility study evaluating the use of the GPX Embolic Device in the peripheral vasculature. The primary objectives for this study are to evaluate safety and early indicators of performance for the GPX Embolic Device and to support the development of a pivotal clinical trial.
Eligibility
Inclusion Criteria5
- Subject presenting with need for durable embolization or pre-operative embolization of a distally-flowing tapering vessel (or vessel bed) including vascular tumours (e.g., renal angiomyolipoma, renal cell carcinoma) and portal vein branches.
- Subject is =18 years of age with an expected lifespan sufficient to allow for completion of study procedure and follow-up visit, if appropriate based on standard of care
- Subject has been informed of the nature of the study and agrees to its provisions and has provided informed written consent (signed the Participant Information Sheet and Consent Form).
- Subject must be willing and able to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits, if appropriate based on standard of care.
- Subject has vascular anatomy that meets the requirements of the IFU.
Exclusion Criteria9
- Subject unwilling or unable to consent.
- Subject’s access vessel(s) preclude safe insertion of delivery catheter or catheter is unable to be advanced to targeted location.
- Subject has a known allergy or hypersensitivity to contrast media that cannot be adequately medicated.
- Subject who is pregnant, or breastfeeding
- Subject who is judged unable or unwilling to comply with required follow up visit (if follow-up visit is appropriate based on standard of care).
- Subject with unresolved systemic infection.
- Subject’s required pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the Investigator, would clinically interfere with the study endpoints.
- Subject has another medical condition which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, may confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up clinical evaluations.
- Subject is participating in another investigational research study investigating a device, drug, or procedure that has not completed the study treatment or that clinically interferes with these study endpoints (Post-approval registries are allowed as long as the Investigator determines there is no clinical interference with study endpoints).
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Interventions
This study involves blood vessel embolization, under fluoroscopic guidance, using the GPX Embolic Device. Participants will undergo a transcatheter embolization procedure, performed by a medical doctor (i.e., an interventional radiologist or vascular surgeon) in a hospital setting typically in under one hour, where GPX Embolic Device will be injected to a blood vessel needing to be treated. Once deployed in the subject's blood vessel, the GPX Embolic device will solidify to a gel-like solid within a few minutes. GPX Embolic Device will then remain in the patient throughout their lifetime. GPX Embolic Device will only be delivered to the subject once, and only up to 3mL of GPX Embolic Device will be administered. GPX administration will be personalised to each patient based on their health condition and their doctor's treatment decisions. Subjects will be contacted for 7-day and 30-day follow-ups. The patient may undergo an additional imaging procedure along with their final follow-up to view the GPX Embolic Device and affected anatomy. Participants will receive a Patient Information Sheet prior to consenting to the study informing them of the procedure and study. Physicians and staff involved in the study will be trained on the use of the device and on the study protocol and procedures. They will receive the study protocol, Investigator's Brochure, and other study materials (e.g., Case Report Forms) to enable them to enroll subjects and follow them through the study period.
Locations(2)
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ACTRN12620001194954