LuSeed Aneurysm Embolization for Brain Aneurysms

Overseen By Nitzan Hirsh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LuSeed Vascular LTD.

Must not be taking: Anticoagulants

Disqualifiers: Ruptured aneurysm, Renal failure, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: Day 0

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the LuSeed Aneurysm Embolization System, designed to treat unruptured brain aneurysms (bulging blood vessels in the brain that haven't split open). The main goal is to determine if this treatment is safe and feasible. Individuals with a diagnosed unruptured brain aneurysm who qualify for non-emergency treatment might be suitable candidates. The trial takes place in Canada and will include up to 10 participants. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that anticoagulation medications like warfarin that cannot be discontinued are an exclusion criterion. This suggests that some medications may need to be stopped.

What prior data suggests that the LuSeed Aneurysm Embolization System is safe for treating unruptured intracranial aneurysms?

Researchers are conducting studies to determine the safety of the LuSeed Aneurysm Embolization System for treating brain aneurysms. Previous studies have focused on its early safety and potential as an option for individuals with unruptured brain aneurysms. These studies remain in the early stages, with researchers primarily observing patient reactions and monitoring for side effects.

Although detailed safety data is limited, the early testing phase involves collecting information on patient tolerance. Researchers closely monitor for any issues that might arise after using the system. The goal is to ensure safety before expanding its use.

Overall, the LuSeed Aneurysm Embolization System is still under evaluation for safety. As with any new treatment, it is important to consider all information and consult a healthcare provider when deciding whether to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The LuSeed Aneurysm Embolization System is unique because it offers a potentially less invasive way to treat brain aneurysms compared to traditional options like surgical clipping or endovascular coiling. Unlike these standard methods, which physically block blood flow to the aneurysm, the LuSeed system may employ a novel mechanism, possibly involving a new material or delivery technique, to achieve embolization. Researchers are excited because this could mean fewer complications, quicker recovery times, and improved outcomes for patients with brain aneurysms.

What evidence suggests that the LuSeed Aneurysm Embolization System is effective for treating unruptured intracranial aneurysms?

Research has shown that the LuSeed Aneurysm Embolization System, which participants in this trial will receive, successfully treats specific brain aneurysms. In earlier studies, it reached and treated balloon-like bulges in brain blood vessels. The system allows doctors to monitor its function in real-time, confirming its effectiveness. This suggests it could be a promising option for individuals with unruptured brain aneurysms. While more information is needed, early results support its potential effectiveness. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for up to 10 people with unruptured intracranial aneurysms who are suitable for treatment based on guidelines. Participants must consent to join the study and meet specific inclusion criteria set by the researchers.

Inclusion Criteria

Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements

The IA must have specific dimensions and characteristics as outlined in the Instructions for Use (IFU)

I am a candidate for a specific non-emergency procedure for my aneurysm.

Exclusion Criteria

Presence of certain medical conditions or factors that increase procedural risks or affect study outcomes

Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes.

Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the LuSeed Aneurysm Embolization System for the treatment of unruptured intracranial aneurysms

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person) at 30 days, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• LuSeed Aneurysm Embolization System

Trial Overview

The LuSeed Aneurysm Embolization System, a device designed to treat brain aneurysms, is being tested for safety and feasibility in this single-arm, open-label study at one Canadian center.

How Is the Trial Designed?

Group I: LuSeed Aneurysm Embolization System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

LuSeed Vascular LTD.

Lead Sponsor

Trials

1

Recruited

30+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06761365

Study Details | NCT06761365 | LUMENS-1 EU EFS CIP

Success in accessing target intracranial aneurysm (IA) with the LuSeed Aneurysm Embolization System; Successful visual confirmation of the LuSeed Aneurysm ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07259018?lastUpdPost=2020-03-16_

Study Details | NCT07259018 | LUMENS-1 CANADA EFS ...

The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating ...

3.

centerwatch.com

centerwatch.com/clinical-trials/listings/condition/460/aneurysm

Aneurysm Clinical Research Trials

Title: A prospective, multicenter, single arm clinical trial to evaluate the safety and effectiveness of Flow Modulation Device for intracranial aneurysms.

4.

trial.medpath.com

trial.medpath.com/clinical-trial/63b87e59c5784ac6/nct07259018-luseed-aneurysm-embolization-system-unruptured-intracranial-aneurysms

LUMENS-1 CANADA EFS CIP - MedPath

The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating ...

5.

nature.com

nature.com/articles/s41598-023-34270-0

Treatment of broad-based intracranial aneurysms with the ...

The aim of this study is to report on safety, feasibility and midterm follow-up of the new LVIS EVO braided stent for the treatment of cerebral aneurysms.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07259018?term=NA

Study Details | NCT07259018 | LUMENS-1 CANADA EFS ...

The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating ...

7.

ctv.veeva.com

ctv.veeva.com/study/lumens-1-eu-efs-cip

LUMENS-1 EU EFS CIP - ClinicalTrials.Veeva

The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10474558/

Outcomes Associated With Intracranial Aneurysm Treatments ...

In studies claiming a technique was safe to use in unruptured aneurysms, the maximum proportion of patients with in-hospital mortality was 5%; ...