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Pseudoaneurysm clinical trials

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NCT ID: NCT06456125 Active, not recruiting - Hemorrhage Clinical Trials

Safety and Efficacy Of Amber Peripheral Liquid Embolic System

OPAL
Start date: June 12, 2024
Phase: N/A
Study type: Interventional

A prospective, single-arm, multicenter, open-label, First-in-Human & Pivotal Study to assess the safety and efficacy of amber SEL-P in 70 patients requiring peripheral embolization: vascular anomalies, hemorrhages, aneurysms, and pseudoaneurysms, varicose veins, portal vein, hypervascular tumors, type -II endoleaks, and pathological organs. The study will be divided into two consecutive stages. Stage I will be dedicated to testing the device's safety, followed immediately by stage II, aimed to test the device's efficacy. The overall study sample will be used to assess the device safety and efficacy in all the enrolled participants.