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New brain bleed treatment shows promise in major trial

NCT ID NCT04410146

Disease control Sponsor: Balt USA Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a procedure called middle meningeal artery embolization using a special gel (SQUID) to treat chronic subdural hematoma, a condition where blood collects between the brain and its outer covering. 319 adults with a large blood collection were randomly assigned to receive the procedure or standard care. The goal was to see if the procedure could reduce the need for repeat surgery and prevent complications like stroke or death within 180 days.

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

319 people

The number who actually took part.

Started

Nov 2020

Finished

May 2024

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

30 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. Male or female Subject whose age is ≥ 30 at the time of consent 2. Pre-morbid mRS (Modified Rankin Scale) 0-1 within the previous 12 months 3. cSDH measures ≥ 10 mm in greatest thickness 4. cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift 5. Imaging characteristics indicative of chronicity (≥ 50% of the volume of the collection should be isodense or hypodense to normal cortical gray matter on Computed Tomography (CT)) 6. Subject presents with one or more of the following neurological symptoms: headache; cognitive decline; speech difficulty or aphasia; gait impairment or imbalance; focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop); and/or seizure 7. Subject, or his/her legally authorized representative, understands the nature of the procedure, consents to participation in the study and provides a signed Informed Consent Form 8. Female Subjects of child-bearing potential must be able to provide a current negative urine pregnancy test and agree to an appropriate method of contraception throughout the trial 9. Subject is able and willing to return to the investigational site for all follow-up visits (e.g., 30-day, 90-day, 180-day and 1-year), as required per protocol Exclusion Criteria: 1. Subject with prior ipsilateral craniotomy or burr hole evacuation of cSDH 2. Subject with prior Embolization of either MMA 3. Subject requires (in the opinion of the treating surgeon) a full or mini craniotomy 4. Subject with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed 5. Subject with a cSDH with a focal location (confined to the frontal or temporal base or the inter-hemispheric space without cerebral convexity involvement) 6. cSDH developed due to underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or secondary to a previous craniotomy 7. Life expectancy of \<1 year 8. Subject who presents with an intracranial mass other than subdural hematoma 9. Subject who presents with a meningioma with mass effect and/or ≥1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region 10. Subject with serum creatinine level \> 3.0 mg/dL at time of enrollment (this will restrict the use of contrast) and not on dialysis 11. Subject with significant liver function impairment at the time of enrollment 12. Subject with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically) 13. Subject who is currently enrolled in another investigational study protocol that could potentially confound the current study endpoints

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural, Chronic Hematoma, Subdural, Intracranial

As listed by the trial registrant

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

Subdural hematoma, chronic

Contacts and locations

Locations

  • Baptist Health

    Jacksonville, Florida, 32207, United States

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120, United States

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • CHU Hopital Bicetre

    Le Kremlin-Bicêtre, 94275, France

  • CHU Hopital Maison Blanche

    Reims, France

  • Carondolet St. Joseph's

    Tucson, Arizona, 85711, United States

  • Chu Cote de Nacre

    Caen, 14000, France

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Gregorio Maranon Hospital

    Madrid, 28007, Spain

  • Hopital Pitie Salpetriere

    Paris, France

  • Johns Hopkins Medicine

    Baltimore, Maryland, 21287, United States

  • Klinikum Nurnberg Sud

    Nuremberg, Germany

  • Los Robles Hospital and Medical Center

    Thousand Oaks, California, 92360, United States

  • Methodist University Hospital

    Memphis, Tennessee, 38104, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Nebraska Health

    Omaha, Nebraska, 68106, United States

  • Overlook Medical Center

    Summit, New Jersey, 07901, United States

  • Penn State Health Hershey Medical Center

    Hershey, Pennsylvania, 17918, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Riverside Community Hospital

    Riverside, California, 92501, United States

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • Swedish Cherry Hill

    Seattle, Washington, 98122, United States

  • Swedish Medical Center

    Englewood, Colorado, 80113, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Kansas

    Kansas City, Kansas, 66160, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Universitätsklinikum Heidelberg

    Heidelberg, Germany

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

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