Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT05686733
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.
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.
Study:
NCT05686733
Study Brief:
Protocol Section:
NCT05686733