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New brain bleed treatment could reduce need for repeat surgery

NCT ID NCT07541404

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new device (NeoCast) that blocks a specific artery in the brain to treat a type of bleeding called subdural hematoma. The goal is to see if it works as well as or better than an existing treatment (Onyx) to prevent the blood from coming back or needing another surgery. About 360 adults with symptoms like headache or confusion will be enrolled.

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 360 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

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 to 90 years

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: * Participant whose age is ≥ 18 and ≤ 90 years; * Pre-morbid mRS ≤ 2; * Confirmed diagnosis of subacute or chronic subdural hematoma that measures ≥10 mm in greatest thickness; * Participant presents with one or more of the following corroborating neurological symptoms: headache; cognitive decline; speech difficulty; gait impairment or imbalance; focal neurological deficit; and/or seizure, within the last 30 days; * Participant is planned for middle meningeal artery embolization within ±7 days of surgical evacuation of hematoma via burr hole or craniotomy; * Participant or Legally Authorized Representative/Person Responsible for consenting on their behalf understands the nature of the procedure, consents to participation in the study and provides a signed informed consent form; * Participant (woman of child-bearing potential) with a current negative pregnancy test who has agreed to an appropriate method of contraception throughout the trial; * Participant is willing to return to the investigational site for follow-up visits. Exclusion Criteria: * Diagnosed with acute SDH * Participant with prior embolization of either MMA * Participant with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed * Participant with bilateral SDH where both sides require surgery or contralateral SDH \>5mm in greatest thickness * Participant identified with potentially dangerous anatomic variations leading to increased procedural risk, risk of incomplete embolization, or unsafe access for MMA embolization (i.e., MMA originating from ophthalmic artery) * Participant who presents with a meningioma ≥1 cm or \< 1 cm with mass effect * Subjects with conditions placing them at high-risk for ischemic stroke who cannot be taken off anticoagulants for at least 7 days post-surgery * Participant currently undergoing radiation therapy for carcinoma or sarcomas of the head or neck region * SDH developed due to underlying condition or structure pathology (e.g., dural AV fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt, spontaneous intracranial hypotension or previous craniotomy) * Presumed microbial superinfection * Participant who is breastfeeding * Participant with life expectancy of \<1 year * Participants with acute renal impairment that the investigator assesses could be at risk for contrast induced nephropathy * Participant with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically) * Participant is allergic to any of the materials used in the NeoCast device or the Onyx LES commercial embolic device * Participant who is currently participating or planning to participate within 6 months in another clinical research study

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Conditions

The condition(s) this trial relates to.

Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 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

  • University of Washington Medicine - Harborview Medical Center

    Seattle, Washington, 98104, United States

  • Yale Neurosciences Institute

    New Haven, Connecticut, 06519, United States

More trials for these conditions

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