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
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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.
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ACTRN12620001194954