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

NCT07079956 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-23

No results posted yet for this study

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

Conditions

  • Aneurysm Cerebral

Interventions

DEVICE

TUBE Flow Diverter

TUBE Device

Sponsors & Collaborators

  • BioMDg

    collaborator UNKNOWN

  • RARAS CRO

    collaborator UNKNOWN

  • NVMedTech

    lead INDUSTRY

Principal Investigators

  • Michel E. Frudit · Hospital das Clínicas da Faculdade de Medicina da USP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07079956 on ClinicalTrials.gov