MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma (NCT07541404) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma
United States150 participantsStarted 2026-07
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the NeoCast Embolic System for treatment of symptomatic subacute or chronic subdural hematoma (SDH) adjunctive to surgery.
Who can participate
Age range18 Years – 90 Years
SexALL
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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 …
What they're measuring
1
Comparison of NeoCast arm vs. FDA-approved commercial liquid embolic for demonstration of successful embolization of the middle meningeal artery
Timeframe: 90 Days post-treatment
2
Safety Outcomes including Device-related or Procedure-related Serious Adverse Events