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Intrasaccular Bridging System

Medical Device for Brain Aneurysm (TORNADO-US Trial)

N/A
Recruiting
Research Sponsored by EndoStream Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is neurologically stable with a Hunt & Hess score of I, II, or III.
Subject is ≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

TORNADO-US Trial Summary

This trial will test a device to treat brain aneurysms that could help save lives.

Who is the study for?
This trial is for adults over 18 with a specific type of ruptured brain aneurysm that's wide (4-7mm) and has a dome size of at least 5mm. Participants should be neurologically stable, able to consent, and follow the study schedule. It excludes pregnant women, those with recent neurological issues or serious health conditions, certain pre-existing diseases like Moyamoya disease, allergies to Nickel/Heparin, or involvement in another clinical study.Check my eligibility
What is being tested?
The Nautilus Intrasaccular Bridging System is being tested for its safety and potential benefits in treating wide-neck ruptured brain aneurysms. The device aims to stabilize the aneurysm and prevent further bleeding into the brain.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include typical risks associated with medical devices for aneurysms such as reaction to materials used in the device (like Nickel), complications from invasive procedures like bleeding or infection, and any specific reactions related to this new system.

TORNADO-US Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My brain function is stable with a mild to moderate condition.
Select...
I am 18 years old or older.
Select...
I have a recently burst brain aneurysm that is 4-7mm wide.

TORNADO-US Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of subjects experiencing death or stroke
Secondary outcome measures
Coil/Device entanglement
Distribution of parent vessel compromise
Technical Success
+3 more

TORNADO-US Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients treated with the deviceExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

EndoStream MedicalLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Nautilus Intrasaccular Bridging System (Intrasaccular Bridging System) Clinical Trial Eligibility Overview. Trial Name: NCT05550571 — N/A
Nautilus Intrasaccular Bridging System (Intrasaccular Bridging System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05550571 — N/A
Brain Aneurysm Research Study Groups: Patients treated with the device
Brain Aneurysm Clinical Trial 2023: Nautilus Intrasaccular Bridging System Highlights & Side Effects. Trial Name: NCT05550571 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are actively participating in this medical experiment?

"Affirmative. ClinicalTrials.gov holds data that indicates this trial is currently recruiting participants, beginning December 17th 2022 and most recently updated February 15 2023. It requires 45 patients to be enrolled across 1 site."

Answered by AI

Is recruitment still active for this clinical trial?

"Correct. According to the information presented on clinicaltrials.gov, this medical study is still recruiting participants; it was first uploaded on December 17th 2022 and most recently updated February 15th 2023. Up to 45 individuals are needed from a single trial site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Medical Device to Treat Wide-Neck Brain Aneurysms
2022. "A Medical Device to Treat Wide-Neck Brain Aneurysms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05550571.
~14 spots leftby Dec 2024
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