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Safety and Efficacy Of Amber Peripheral Liquid Embolic System

NCT06456125 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-06-17

No results posted yet for this study

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.

Conditions

  • Vascular Anomalies
  • Hemorrhage
  • Aneurysm
  • Pseudoaneurysm
  • Varicose Veins
  • Portal Vein Embolization
  • Hypervascular Tumor
  • Type II Endoleak
  • Pathological Organ

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.

Sponsors & Collaborators

  • LVD Biotech S.L

    lead INDUSTRY

Principal Investigators

  • Fernando Gómez · Hospital Universitario La Fe

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
94 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06456125 on ClinicalTrials.gov