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New device aims to seal brain aneurysms and prevent strokes

NCT ID NCT07143019

Disease control Sponsor: phenox Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 8 times

Summary

This study is testing a device called a flow modulator to treat wide-necked brain aneurysms. The device is placed inside the artery to redirect blood flow away from the aneurysm, helping it close off. Researchers will check if the device is safe and effective in 214 adults over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
p48 MW HPC and p64 MW HPC Flow Modulation Device
What this could lead to
If successful, this device could offer a safe and effective way to treat wide-necked brain aneurysms, reducing the risk of stroke or rupture.
What could go wrong
This is a single-arm trial without a comparison group, so results may be less definitive. Risks include stroke or neurological death from the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 214 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jul 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is ≥ 18 years 2. Subject has a mRS ≤2 before the index procedure 3. Subject has an unruptured or recanalized intracranial aneurysm (IA). The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the index procedure. The IA must have the following characteristics below: 1. Saccular or fusiform morphology 2. Located in the internal carotid artery and its branches 3. Aneurysm neck ≥4 mm or dome-to-neck ratio \<2 4. Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA 4. Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures. Exclusion Criteria: 1. Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated 2. Any other known IA requiring treatment within 3 months post-procedure 3. Subarachnoid hemorrhage in the past 30 days prior to the index procedure 4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation 5. Anatomy unsuitable for endovascular procedure due to severe vessel tortuosity or stenosis, or stented ipsilateral carotid artery within 3 months prior to the index procedure 6. Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm 7. Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date 8. Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days) 9. Known serious sensitivity to radiographic contrast agents that cannot be managed medically 10. Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components 11. Irreversible bleeding disorder and/or signs of active bleeding at subject presentation 12. Known renal failure with a serum creatinine \>2.5 mg/dl (or 220 μmol/l) not on dialysis 13. Contraindication to CT scan, MRI, or angiography 14. Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor) 15. Known coagulopathy, or an admission International Normalized Ratio \>3.0 without oral anticoagulation therapy, or an admission platelet count of \<100000 16. Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial 17. Unable to complete the required study follow-ups 18. Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count) 19. Participating in another clinical trial that could affect participation or primary outcomes of this study 20. Women currently pregnant or wish to become pregnant during the study or breast feeding.

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Conditions

The condition(s) this trial relates to.

Aneurysm Bites and Stings brain aneurysm hemorrhagic stroke intracranial berry aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aneurysm, intracranial Brain aneurysm Fusiform aneurysm Hemorrhagic stroke Saccular aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Lutheran General Hospital

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Baptist Health Research Institute

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Barrow Neurological Institute

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • East Carolina University Health Medical Center

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • NewYork-Presbyterian / Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10065, United States

  • North Shore University Hospital - Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

  • Northwestern Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University Hospital (OHSU) / Oregon Stroke Center

    RECRUITING

    Portland, Oregon, 97239, United States

  • Piedmont Atlanta Hospital

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Swedish Medical Research Center

    RECRUITING

    Englewood, Colorado, 80113, United States

  • The University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UBNS

    RECRUITING

    Buffalo, New York, 14203, United States

  • UCSF Medical Center

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Colorado Anschutz

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Southern California Health Sciences / Keck Hospital of USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Utah Health

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Washington - Harborview Medical Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • WashU Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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