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NOT YET RECRUITING
NCT07259018
NA

LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

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 single-arm, open-label, single-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 10 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled in a Canadian site.

Official title: A Single-arm, Open Label, Single-center Early Feasibility Study of the LuSeed Aneurysm Embolization System in Individuals With Unruptured Intracranial Aneurysms.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-12

Completion Date

2028-05

Last Updated

2025-12-09

Healthy Volunteers

No

Interventions

DEVICE

LuSeed Aneurysm Embolization System

LuSeed Aneurysm Embolization System EFS Canada

Locations (1)

St. Michael's Hospital - Unity Health Toronto

Toronto, Ontario, Canada