Evaluation of a Simple-Prep Controlled Embolic (NCT06453642) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of a Simple-Prep Controlled Embolic
United States, Canada, New Zealand114 participantsStarted 2024-11-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom from major adverse events (MAEs)
Timeframe: Index procedure through 30-day follow-up
2
Single binomial proportion of successful delivery of the GPX Embolic Device to the target vessel embolization site(s)
Timeframe: During procedure
3
Single binomial proportion of successful occlusion of flow immediately beyond the target vessel embolization site(s)
. 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
. 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