NCT07259018

LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: LuSeed Vascular LTD. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

LuSeed Vascular will sponsor the study and the study will assess early safety and feasibility of the LuSeed Aneurysm Embolization System for the treatment of unruptured intracranial aneurysms (IA).

Conditions

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

Interventions

Type	Name	Description
DEVICE	LuSeed Aneurysm Embolization System	LuSeed Aneurysm Embolization System EFS Canada

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-01
• Completion: 2028-05-01
• First posted: 2025-12-02
• Last updated: 2025-12-09

Locations

1 site across 1 country: Canada