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ACTIVE NOT RECRUITING Phase 3

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

NCT05831202 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DEVICE The SEAL™ Saccular Endovascular Aneurysm Lattice System

Study Locations (6)

Illinois

  • Endeavor Health - Northwest Community Hospital — Arlington Heights
  • Endeavor Health - Evanston Hospital — Evanston
  • Endeavor Health- Edward Hospital — Naperville

New York

  • NYU Langone Health — New York
  • Stony Brook University Hospital — Stony Brook

New Jersey

  • The Cooper Health System — Camden

Trial Details

FieldValue
Enrollment Target 279 participants
Start Date 2024-08-06
Est. Completion 2030-09-10
Phase Phase 3

Sponsor

Galaxy Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05831202

The ClinicalTrials.gov registry entry for NCT05831202 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galaxy Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Intracranial Aneurysm appearing as the primary indexed condition, and to 1 intervention — of which The SEAL™ Saccular Endovascular Aneurysm Lattice System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05831202 reports 6 study locations spanning 3 distinct geographic areas — top geographies include Illinois, New York, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05831202 about?

NCT05831202 is a clinical study titled "SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial". 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.

What is the current status of trial NCT05831202?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 279 participants. The study started on 2024-08-06. Estimated completion is 2030-09-10.

What conditions does trial NCT05831202 study?

This clinical trial studies the following conditions: Intracranial Aneurysm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05831202?

The interventions under investigation include: The SEAL™ Saccular Endovascular Aneurysm Lattice System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05831202?

This trial is sponsored by Galaxy Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05831202 being conducted?

This trial has 6 study locations across Illinois, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial