NCT05686733

Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Galaxy Therapeutics INC · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aneurysms Saccular
• Aneurysm, Ruptured
• Aneurysm

Interventions

Type	Name	Description
DEVICE	SEAL Device	Endovascular treatment of target aneurysm using the Saccular Endovascular Aneurysm Lattice (SEAL) device.

Timeline

• Start date: 2022-01-26
• Primary completion: 2024-02-17
• Completion: 2024-02-17
• First posted: 2023-01-17
• Last updated: 2024-04-04

Locations

1 site across 1 country: Colombia