Liquid embolization may offer Needle-Free alternative to brain surgery for blood clots
NCT ID NCT07576998
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new approach for treating chronic subdural hematoma (a blood clot on the brain) using a liquid called PHIL™ that is injected into the middle meningeal artery to block blood flow to the clot. The trial will compare this minimally invasive procedure to standard surgical drainage in 475 adults aged 22 and older. The goal is to see if the liquid embolization can effectively resolve the hematoma without requiring surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PHIL™ (Precipitating Hydrophobic Injectable Liquid) - a liquid used to block blood vessels
- What this could lead to
- If successful, this could offer a less invasive first-line treatment for chronic subdural hematoma, potentially reducing the need for surgery and its risks.
- What could go wrong
- This is an early-stage trial (Phase NA) with 475 participants, so results may not apply to all patients. The procedure carries risks like stroke or incomplete hematoma resolution.
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 475 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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May 2031
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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22 years and older
- 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: * Age 22 years or older * Diagnosis of chronic subdural hematoma * Subject, or their legally authorized representative provides a signed and dated Informed Consent Form * Pre-morbid mRS 0-1 * cSDH measures ≥ 10 mm in greatest thickness * cSDH exerts mass effect upon the subjacent brain * Imaging characteristics indicative of chronicity * Negative urine pregnancy test for female subjects of child-bearing potential * Subject is able and willing to comply with all study protocol requirements, including return to the investigational site for all follow-up visits * Subject presents with one or more of the following neurological symptoms: headache/head pressure, 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 Exclusion Criteria: * Prior ipsilateral craniotomy or burr hole evacuation of cSDH * Prior embolization of either MMA * Requires (in the opinion of the treating surgeon) full or mini-craniotomy at time of randomization * Emergent subdural hematoma evacuation needed * cSDH with a focal location * cSDH developed due to underlying condition * Life expectancy of \<1 year * Presents with an intracranial mass other than subdural hematoma * 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 * Serum creatinine level \> 3.0 mg/dL at time of enrollment and not on dialysis * Life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically) * Currently enrolled in another investigational study protocol that could potentially confound the interpretation of the study endpoints/outcomes * Known dangerous anatomic variations leading to increased procedural risk or unsafe access for MMAE * Contraindicated for the use of PHIL™ liquid embolic system
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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 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.
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