RecruitingACTRN12620001194954

Use of the GPX Embolic Device in Patients Requiring Embolization

A Feasibility Study of the GPX Embolic Device


Sponsor

Fluidx Medical Technology, LLC

Enrollment

20 participants

Start Date

Nov 17, 2020

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This is a first-in-human feasibility study testing a new medical device called the GPX Embolic Device, which is designed to block blood flow to specific vessels in the body. Embolization procedures (deliberately blocking blood vessels) are used to treat conditions like kidney tumours, vascular abnormalities, and to prepare for surgery. The GPX device represents a new approach to achieving reliable and lasting vessel blockage. As a first-in-human study, the primary goal is to confirm the device is safe and to observe early signs of how well it performs. There is no comparison group — all participants receive the device during a standard embolization procedure. Participants are followed up after the procedure to assess safety outcomes and recovery. You may be eligible if you are 18 or older and have a medical condition that requires a durable embolization procedure (such as a kidney tumour or portal vein treatment), have appropriate anatomy for the device, and are willing and able to attend follow-up visits. People who cannot consent, have systemic infection, or are pregnant or breastfeeding are not eligible.

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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 do

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)

Auckland, New Zealand

Canterbury, New Zealand

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ACTRN12620001194954


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