Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 6:05 PM
Study NCT ID:
NCT07079956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms
Sponsor:
NVMedTech
Organization:
Study Overview
Official Title:
A Prospective, Single-Arm, Multicenter, Feasibility Trial to Evaluate the Safety and Performance of the TUBE Device in the Endovascular Treatment of Unruptured, Wide-Neck or Fusiform Intracranial Aneurysms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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:
NV01
Brief Summary:
To assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, wide-neck or fusiform intracranial aneurysms located on the internal carotid artery (ICA) or its branches
Detailed Description:
This is a prospective, single-arm, multicenter study designed to assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio \< 2) or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm and located on the ICA or its branches.
Up to 20 eligible patients who present for flow diverter placement, provide informed consent, meet all inclusion crite-ria, and not meet any exclusion criteria will receive treatment with the TUBE device. All participants will be followed for 1 year. Post-procedure, imaging will be repeated at the Day 30, Month 3, 6, and 12 visits.
Up to 20 eligible patients who present for flow diverter placement, provide informed consent, meet all inclusion crite-ria, and not meet any exclusion criteria will receive treatment with the TUBE device. All participants will be followed for 1 year. Post-procedure, imaging will be repeated at the Day 30, Month 3, 6, and 12 visits.
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?:
True
Is an FDA AA801 Violation?: