Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 4:57 AM
Study NCT ID:
NCT05686733
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2022-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial
Sponsor:
Galaxy Therapeutics INC
Organization:
Study Overview
Official Title:
Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Pre-SEAL™IT
Brief Summary:
To establish the preliminary safety and effectiveness of the SEAL™ Endovascular Aneurysm Lattice System for the treatment of saccular intracranial aneurysms.
The data from this study will be used to support:
1. EU CE Mark labelling
2. US FDA Investigational Device Exemption (IDE) approval support of PMA approval.
The data from this study will be used to support:
1. EU CE Mark labelling
2. US FDA Investigational Device Exemption (IDE) approval support of PMA approval.
Detailed Description:
First In Human (FIH), prospective, single-arm, multicenter, interventional study. Patients presenting with evidence of a single unruptured or ruptured aneurysm requiring treatment will be enrolled into the study and treated using the SEAL™ System.
Immediate post-procedure angiographic findings, clinical presentation, safety, and imaging follow-up for each subject will be collected at 24 hours, 3 (MRA), 6, 12 and 24-months post-procedure.
Immediate post-procedure angiographic findings, clinical presentation, safety, and imaging follow-up for each subject will be collected at 24 hours, 3 (MRA), 6, 12 and 24-months post-procedure.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: