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Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)

Recruitingn/aAges 18 Years - anyAllAesculap AG
NCT07258069 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years old or older * Confirmed diagnosis of chronic subdural hematoma (CSDH) or recurrent subdural hematoma (SDH) * Completed documented informed consent * Willingness and presumed capability to participate in follow-up visits for up to 6 months (180±30 days) Exclusion Criteria: * Extensive cerebral infarction, brain tumor, or space-occupying lesion requiring treatment * Need craniotomy * Any sign of anatomical variations that could make MMA embolization unsafe (e.g., prominent MMA-opthalmic artery anastomoses) * Coagulation dysfunction with INR\>1.8 and/or platelet count \<80x109 /L * Allergic reactions to essential medicines to do angiography * Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study * Participation in another clinical trial
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What it tests

  • Histoacryl®
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Where

6 sites
Kokura Memorial Hospital
Fukuoka, Japan
Ohara HealthCare Foundation Kurashiki Central Hospital
Okayama, Japan
Shimizu Hospital
Kyoto, Japan
National Hospital Organization Osaka National Hospital
Osaka-Fu, Japan
Kyoto University Hospital
Kyoto, Japan
National Cerebral and Cardiovascular Center
Osaka, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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