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ACTIVE NOT RECRUITING
NCT06456125
NA

Safety and Efficacy Of Amber Peripheral Liquid Embolic System

Sponsor: LVD Biotech S.L

View on ClinicalTrials.gov

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.

Official title: Safety and Efficacy Of Amber Peripheral Liquid Embolic System: a First-in-HumAn & PivotaL Study

Key Details

Gender

All

Age Range

18 Years - 94 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-06-12

Completion Date

2026-12

Last Updated

2024-06-17

Healthy Volunteers

No

Interventions

DEVICE

amber SEL-P Peripheral Liquid Embolic System

Transcatheter arterial or venous embolization with the liquid embolic agent amber SEL-P embolization across seven different indications for peripheral embolization.

Locations (1)

Hospital Universitario Y Politécnico La Fe

Valencia, Spain