An interventional study of Surgical Management and Onyx™ Liquid Embolic System (LES) Embolization in Subdural Hematoma, sponsored by Medtronic Neurovascular Clinical Affairs. Completed at 49 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Medtronic Neurovascular Clinical Affairs (part of Medtronic) · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)
44 studies on the registry are indexed under Hematoma, Subdural; 15 are open to participants now.
This study's enrollment of 600 is above the median of 105 across 30 interventional studies indexed under Hematoma, Subdural.
Browse Hematoma, Subdural studies →Medtronic Neurovascular Clinical Affairs is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Surgical Management
Device: Onyx™ Liquid Embolic System (LES) Embolization · Procedure: Surgical Management
Other: Observation Only
Device: Onyx™ Liquid Embolic System (LES) Embolization
Surgical Evacuation of the Subdural Hematoma (SDH) (Control)
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Medical Management (Control)
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Surgical Evacuation of the Subdural Hematoma (SDH)
Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline
Time frame: 90 days post-procedure
Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score
Time frame: 90 days post-procedure
Effectiveness: Incidence of hospital readmissions
Time frame: 90 days post-procedure
Effectiveness: Change in hematoma volume based on CT/MRI imaging
Time frame: 90 days post-procedure
Effectiveness: Change in hematoma thickness per CT/MRI imaging
Time frame: 90 days post-procedure
Effectiveness: Change in midline shift based on CT/MRI imaging
Time frame: 90 days post-procedure
Safety: Incidence of device-related serious adverse events
Time frame: 30 days post-procedure
Safety: Incidence of procedure-related serious adverse events
Time frame: 30 days post-procedure
Safety: Incidence of neurological death
Time frame: 90 days and 180 days post-procedure
Safety: Incidence of device-related adverse events
Time frame: 90 days and 180 days post-procedure
Plan to share: No — No individual participant data will be available
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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