Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT05831202
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2023-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial
Sponsor:
Galaxy Therapeutics INC
Organization:
Study Overview
Official Title:
SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEAL™IT
Brief 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.
The data from this study will be used to support a premarket approval (PMA) submission.
Detailed Description:
Prospective, United States (US) and Outside of the United States (OUS) single-arm, multicenter, interventional study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 19 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System. Immediate post-procedure angiographic findings, clinical presentation, safety, and optional imaging follow-up for each subject will be collected at 24 hours or discharge, 3 months, 6 months, and required primary end point 12 months post-procedure. Digital subtraction angiography (DSA) at 12 months will be required imaging for the primary effectiveness endpoint assessment. After the PMA application, subjects follow up will continue annually for a total of five years post procedure.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: