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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06456125
Study type Interventional
Source LVD Biotech S.L
Contact
Status Active, not recruiting
Phase N/A
Start date June 12, 2024
Completion date December 2026

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