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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: Active Phase 3 study of Intracranial Aneurysm, sponsored by Galaxy Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion of subjects with successful aneurysm occlusion at 12 months without parent artery stenosis or retreatment, as determined by independent core lab.
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
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2024-08-06 |
| Est. Completion | 2030-09-10 |
| Phase | Phase 3 |
What the registry record for NCT05831202 still lists
NCT05831202 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, below the 9,176-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (97% lower).
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 lists 6 locations in 3 states (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.
Learn More About Clinical Trials
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Where NCT05831202's enrollment target sits among peer trials
279 9th of 14 higher than 6 of 14 other Intracranial Aneurysm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intracranial Aneurysm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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