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LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

NCT07259018 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-09

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 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.

Conditions

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

Interventions

DEVICE

LuSeed Aneurysm Embolization System

LuSeed Aneurysm Embolization System EFS Canada

Sponsors & Collaborators

  • LuSeed Vascular LTD.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-12-31
Completion
2028-05-31

Countries

  • Canada

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 NCT07259018 on ClinicalTrials.gov