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NCT05831202RECRUITINGIRB Ready

SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial

(SEAL™IT)

Sponsored by Galaxy Therapeutics INC

Quick Self-Assessment

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1 of 279 participants interested
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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

To establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms. The data from this study will be used to support a premarket approval (PMA) submission.

Who Can Participate

Inclusion Criteria

22 to 80 years of age at the time of screening. 2. Unruptured aneurysm requiring endovascular treatment suitable for SEAL device and meet the American Heart Association (AHA) guidelines for management of unruptured aneurysm.5 3. Ruptured aneurysm A ruptured aneurysm is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of Subarachnoid Hemorrhage (SAH) attributed to the index aneurysm within the last 60 days. Ruptured aneurysm may be included according to the following criteria: The subject is neurologically stable with no seizure at the onset of the SAH, not requiring External Ventricular Drain (EVD) placement prior to inclusion.
Hunt and Hess scale (HHS) of 2 or less at the time of treatment.
mRS of ≤2 prior to presentation or aneurysm rupture.
Meet the AHA guidelines for management of ruptured aneurysm. 4. The index intracranial aneurysm (IA) to be treated must include the f

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

279 participants

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Age Range

22 Years - 80 Years

Gender

ALL

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Sponsor

Galaxy Therapeutics INC

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Arlington Heights

Illinois

Location available
RECRUITING

Evanston

Illinois

Location available
RECRUITING

Naperville

Illinois

Location available
RECRUITING

Camden

New Jersey

Location available
RECRUITING

New York

New York

Location available
RECRUITING

Stony Brook

New York

Location available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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Looking for Brain Aneurysm Treatment in Arlington Heights?

Join others in Illinois exploring innovative treatment options through clinical research

Brain Aneurysm Treatment Options in Arlington Heights, Illinois

If you're searching for Brain Aneurysm treatment in Arlington Heights, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Arlington Heights, Evanston, Naperville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Brain Aneurysm. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Illinois
Now Enrolling
Up to 279 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Brain Aneurysm?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Brain Aneurysm

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Brain Aneurysm Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05831202. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.