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LUMENS-1 EU EFS CIP

NCT06761365 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-26

No results posted yet for this study

Summary

The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA). This is a prospective, single-arm, open-label, multi-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 30 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled across a maximum of 10 medical centers in the EU.

Conditions

  • Aneurysm Cerebral
  • Bifurcation
  • Unruptured Intracranial Aneurysm
  • Saccular Aneurysm
  • Brain Aneurysm

Interventions

DEVICE

LuSeed Aneurysm Embolization System

a permanent intrasaccular implant used for treatment of unruptured intracranial saccular aneurysms (IA) in adult patients according to international guidelines who are indicated for non-emergent endovascular embolization of saccular IAs at the time of presentation.

Sponsors & Collaborators

  • LuSeed Vascular LTD.

    lead INDUSTRY

Principal Investigators

  • Vitor Pereira, MD MSc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-10-07
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Bulgaria
  • Germany
  • Israel
  • Poland

Study Locations

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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 NCT06761365 on ClinicalTrials.gov