New brain bleed treatment could reduce need for repeat surgery
NCT ID NCT07541404
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
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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
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About 360 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Washington Medicine - Harborview Medical Center
Seattle, Washington, 98104, United States
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Yale Neurosciences Institute
New Haven, Connecticut, 06519, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Why a simple fall can cause brain bleeding in older adults
- Cold plasma zaps brain bleed comeback risk in small trial
- Cheap Blood-Clot drug could cut repeat brain surgery risk
- Massive study aims to predict brain surgery success
- New procedure aims to stop brain bleeds from coming back
- Brain bleed breakthrough? new study tests artery blocking to avoid surgery