NCT07079956

Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: NVMedTech · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aneurysm Cerebral

Interventions

Type	Name	Description
DEVICE	TUBE Flow Diverter	TUBE Device

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

3 sites across 1 country: Brazil

Regulatory

• FDA-regulated device study