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New study tests mesh device to seal dangerous brain aneurysms

NCT ID NCT06411418

Disease control Sponsor: Jacobs institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing a device called the Pipeline™ Flex Embolization Device with Shield Technology™ to treat wide-necked brain aneurysms. The device is a small mesh tube that is placed inside the artery to divert blood flow away from the aneurysm, helping it heal. The study will follow 10 adults to see how safe the device is, focusing on whether any blood clots form. The device is already approved for use, so this study is collecting more real-world evidence.

What this could mean

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

Active substance
Pipeline™ Flex Embolization Device with Shield Technology™ (a mesh tube placed inside the artery to divert blood flow away from the aneurysm)
What this could lead to
If successful, this could confirm that the device is a safe and effective option for treating wide-necked brain aneurysms, potentially reducing the need for more invasive surgery.
What could go wrong
This is a very small study (10 people) and is not randomized. It only looks at short-term safety (clotting events), not long-term outcomes. The device is already approved, so this is more about confirming real-world use than discovering something new.

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

10 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

22 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: * Adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. Exclusion Criteria: * Cannot provide consent or legally authorized representative not available to provide consent

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

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

Intracranial aneurysms

Contacts and locations

Locations

  • University at Buffalo Neurosurgery

    Buffalo, New York, 14203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.