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New device aims to gently suck out brain clots without major surgery

NCT ID NCT04494295

Disease control Sponsor: Integra LifeSciences Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This registry tracks 500 adults with a large brain bleed who undergo a minimally invasive procedure using the Aurora Surgiscope. The device helps surgeons see and remove the clot through a small opening. The main goal is to see if the procedure can reduce the clot to less than 15 cc right after surgery. Researchers will also look at how patient selection and timing affect outcomes.

What this could mean

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

Active substance
Aurora Surgiscope System (a surgical device for minimally invasive brain surgery)
What this could lead to
If successful, this registry could show that minimally invasive surgery improves recovery and reduces disability after a brain bleed.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the device works better than other methods. Results may not apply to all patients, and surgery always carries risks like infection or rebleeding.

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.

Participants

About 500 people

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

Started

Oct 2020

Expected to finish

Oct 2029

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.

Who is studied

general population with an acute, spontaneous, primary, supratentorial ICH

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: * Subject Age is \> 18 * Subject with a Head CT that demonstrates an acute, spontaneous, primary, supratentorial ICH of volume \> 20 mL, assessed via standard of care techniques * Subject Surgery can be initiated within 24 hours of the last known well time or, in patients with wake-up onset, within 24 hours of the time the patient awoke with symptoms. * Subject has a NIHSS score \> 5 * Subject has a baseline Modified Rankin Scale (mRS) Score ≤ 2 * Subject with a CT Angiography demonstrating no vascular malformation Exclusion Criteria: * Subject has an underlying vascular lesion defined as causative source of ICH * Subject has a profound neurological deficit defined as fixed/dilated pupils or bilateral extensor motor posturing * Subject has an Infratentorial or brainstem ICH * Subject has a known life expectancy \< 6 months * Subject has an uncorrectable coagulopathy * Subject has a mechanical heart valve * Subject is pregnant * Subject participates in another concurrent interventional clinical trial * Subject who is unable to meet study follow-up requirements

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Conditions

The condition(s) this trial relates to.

intracerebral hemorrhage

As listed by the trial registrant

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

Supratentorial hemorrhage

How to take part

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

  1. The places running it

    18 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

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Corewell Health

    TERMINATED

    Grand Rapids, Michigan, 49503, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • JFK university

    RECRUITING

    Edison, New Jersey, 08820, United States

  • MedStar Health Research Institute

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21237, United States

  • Pennsylvania State University

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Prisma Health - Upstate

    RECRUITING

    Greenville, South Carolina, 29601, United States

  • Providence Health

    RECRUITING

    Burbank, California, 91505, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • UT Health

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • University at Buffalo

    RECRUITING

    Buffalo, New York, 14260, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Missouri

    RECRUITING

    Columbia, Missouri, 65201, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599-1350, United States

  • University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania

    TERMINATED

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Washington - Harborview

    RECRUITING

    Seattle, Washington, 98104, United States

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States