Evaluation of a Simple-Prep Controlled Embolic (NCT06453642) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of a Simple-Prep Controlled Embolic
United States114 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 range18 Years
SexALL
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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
✕. 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
✕
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)
. 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