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Safety and Efficacy Of Amber Peripheral Liquid Embolic System

Study acronym: OPAL
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 17, 2024 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Start date: May 3, 2024 to Jun 12, 2024
    • Primary completion date: May 2026 to Jul 2026
    • Study completion date: Nov 2026 to Dec 2026
    • Eligibility criteria revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06456125
Lead Sponsor LVD Biotech S.L
Conditions
(from sponsor)		 Vascular Anomalies, Hemorrhage, Aneurysm, Pseudoaneurysm, Varicose Veins, Portal Vein Embolization, Hypervascular Tumor, Type II Endoleak +1 more
Related terms Aneurysm, Aneurysm, False, Hemorrhage, Varicose Veins, Vascular Malformations
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov