Aneurysm CerebralPhase 1NV01NCT07079956
Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms
A Phase 1 study testing TUBE Flow Diverter in people with Aneurysm Cerebral, run by NVMedTech at 3 sites in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Aneurysm Cerebral
- What is being tested?
- TUBE Flow Diverter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesBrazil
- Study dates
- Oct 2025to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a single unruptured target intracranial aneurysm (IA) with the following characteristics:
- Is located on the internal carotid artery or its branch-es.
- Has a neck ≥ 4 mm, dome to neck ratio < 2.0, or no discernible neck
- Aneurysm diameter ≤ 35 mm (saccular or fusiform configuration)
- Has a parent vessel diameter ≥ 2.0 mm and ≤ 5.0 mm at both the proximal and distal segments where the implant will be placed.
- Has multiple increased risk factors for intracranial aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of aneurysm rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the patient's expected lifetime if left untreated.
- The patient is able and willing to provide written in-formed consent.
Who cannot join
- Participants are not eligible for the study if ANY of the following criteria are present:
- Has an extradural aneurysm
- Has a target aneurysm in the posterior circulation
- Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from study)
- Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
- Target aneurysm is unsuitable for flow diverter treatment
Show all 26Show fewer
- Has vessel characteristics, such as severe tortuosity (cICA Type IV), stenosis (>70%), or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
- Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
- Has a medical contraindication to study or procedure related antiplatelet medications (aspirin, clopidogrel/ Plavix, prasugrel, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye
- Non-responders to prasugrel as determined by the P2Y12 assay ("VerifyNow" system)
- Has a known severe allergy to nickel titanium, stainless steel (304SS) tantalum, or platinum.
- Modified Rankin Score assessment is ≥ 3 at pre-procedure exam
- Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days)
- Subarachnoid hemorrhage occurred within 30 days prior to enrollment
- Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after enrollment date
- Has more than one intracranial aneurysm that requires treatment within 12 months
- Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date
- Chronic anticoagulation therapy is ongoing or known coagulopathy exists
- Has other known serious concurrent medical conditions such as heart disease (e.g., atrial fibrillation [with or without pacemaker], recent myocardial infarction [< 12 weeks ago], symptomatic congestive heart failure, or carotid stenosis), kidney failure [>2.0mg/dl serum creatinine], pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, terminal cancer, vasculitis, high risk of ischemic stroke or recent stroke
- Has acute life-threatening illness other than the neurological disease (e.g., acute kidney or heart failure) to be treated in this trial
- Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
- Unable to complete study follow up due to dementia or psychiatric problem, substance abuse, or history of noncompliance with medical advice
- Pregnancy at time of enrollment
- Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
- Evidence of active infection at the time of treatment
- Enrollment in another trial involving an investigational product that could confound the outcomes of this trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kathleen Calderon Dr. Director Clinical and Market Affairs, Bachelors contact
Brazil3 sites
Hospital Geral de Fortaleza
Fortaleza, 60150-160
Francisco Mont'Alverne, +55 85 99991-7912, f_montalverne@yahoo.com.br
Instituto Estadual do Cérebro Paulo Niemeyer
Rio de Janeiro, 20231-092
Elias Tanus, +55 21 97145-7565, elias.tanus@gmail.com
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 71205-050
Michel Frudit, +55 11 99689-3433, michel.frudit@hc.fm.usp.br
About this study
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
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
Read the 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
- Being tested
- TUBE Flow Diverter
- Keywords
- Aneurysm, Wide-neck, Fusiform, Flow Diverter
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUBE Flow DiverterDevice
TUBE Device
| Study group | Role | What they receive |
|---|---|---|
| Eligible participants will receive treatment with the TUBE Flow Diverter device | Experimental | the TUBE device is for the treatment of unruptured, saccular wide-neck 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. Receives: Device: TUBE Flow Diverter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic death, or disabling stroke
Primary Safety Outcome
Measured: At 12 months
Primary Performance Outcome
The proportion of participants with composite of 100% occlusion (Raymond-Roy Classification 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (> 50% stenosis) on digital subtraction angiography (DSA) images.
Measured: At 12 months post-procedure
Secondary outcomes (1)
Performance Outcome
The proportion of participants with composite of 100% occlusion (Raymond-Roy Classification 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (> 50% stenosis) and with no retreatment of the target aneurysm.
Measured: 1 month, 3 months, and 6 months post-procedure respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm CerebralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NVMedTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioMDg, RARAS CRO
- Responsible party
- Sponsor
- Investigators
- Michel E. Frudit, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079956
- Sponsor's protocol ID
- NV01
- Acronym
- NV01
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07079956
- Acronym / sponsor ID
- NV01 / NV01
- Conditions
- Aneurysm Cerebral
- Keywords
- Aneurysm, Wide-neck, Fusiform, Flow Diverter
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NVMedTechIndustry (pharma, biotech, devices)
- Collaborators
- BioMDg, RARAS CRO
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible participants will receive treatment with the TUBE Flow Diverter device | Experimental | Device: TUBE Flow Diverterthe TUBE device is for the treatment of unruptured, saccular wide-neck 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. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a single unruptured target intracranial aneurysm (IA) with the following characteristics:
- Has a parent vessel diameter ≥ 2.0 mm and ≤ 5.0 mm at both the proximal and distal segments where the implant will be placed.
- Has multiple increased risk factors for intracranial aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of aneurysm rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the patient's expected lifetime if left untreated.
- The patient is able and willing to provide written in-formed consent.
Key exclusion criteria (26 listed)
- Has an extradural aneurysm
- Has a target aneurysm in the posterior circulation
- Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from study)
- Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
- Target aneurysm is unsuitable for flow diverter treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TUBE Flow DiverterTUBE Device | Device | Eligible participants will receive treatment with the TUBE Flow Diverter device |
Primary outcome
Neurologic death, or disabling stroke
Time frame: At 12 months
Primary Safety Outcome
Primary Performance Outcome
Time frame: At 12 months post-procedure
The proportion of participants with composite of 100% occlusion (Raymond-Roy Classification 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (> 50% stenosis) on digital subtraction angiography (DSA) images.
1 secondary outcome
Performance Outcome
Time frame: 1 month, 3 months, and 6 months post-procedure respectively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen Calderon Dr. Director Clinical and Market Affairs, Bachelors contact
Michel E. Frudit principal investigator
University of Sao Paulo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TUBE Flow Diverter in people with Aneurysm Cerebral, run by NVMedTech at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Calderon Dr. Director Clinical and Market Affairs, Bachelors (307-250-2726, kcalderon@encompassf2.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologic death, or disabling stroke (time frame: At 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.