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Liquid embolization may offer Needle-Free alternative to brain surgery for blood clots

NCT ID NCT07576998

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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 475 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

May 2031

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

22 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: * 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.

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 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 ↗

  2. 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.

More trials for these conditions

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