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RECRUITING
NCT06761365
NA

LUMENS-1 EU EFS CIP

Sponsor: LuSeed Vascular LTD.

View on ClinicalTrials.gov

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.

Official title: A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY OF THE LUSEED ANEURYSM EMBOLIZATION SYSTEM IN INDIVIDUALS WITH UPRUPTURED INTRACRANIAL ANEURYSMS

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-10-07

Completion Date

2027-06

Last Updated

2025-11-26

Healthy Volunteers

No

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.

Locations (6)

University Hospital St. Ivan Rilski

Sofia, Bulgaria

The University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Sheba Medical Center

Tel Litwinsky, Israel

UCK Katowice

Katowice, Poland

Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz

Lodz, Poland

Jan Mikulicz-Radecki University Clinical Hospital in Wrocław

Wroclaw, Poland