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NCT05831202 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Intracranial Aneurysm, sponsored by Galaxy Therapeutics.

Active
Registry status
Phase 3
Development phase
279
Enrollment target
6
Study locations

NCT05831202 is a Phase 3 study of Intracranial Aneurysm that is active but no longer recruiting, run by Galaxy Therapeutics. The registered enrollment target is 279 participants, below the 9,176-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 3 states.

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The verdict

NCT05831202, a Phase 3 study of Intracranial Aneurysm, is active but no longer recruiting, sponsored by Galaxy Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
279 participants
Enrollment target
6
Study locations

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

What the Registry Record Tells You About NCT05831202

The ClinicalTrials.gov registry entry for NCT05831202 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,176-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (97% lower). The listed sponsor is Galaxy Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT05831202 reports 6 study locations spanning 3 distinct geographic areas - top geographies include Illinois, New York, New Jersey.

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.

What interventions are being tested in trial NCT05831202?

The interventions under investigation include: The SEAL™ Saccular Endovascular Aneurysm Lattice System (DEVICE).

Who is sponsoring clinical trial NCT05831202?

This trial is sponsored by Galaxy Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

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

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