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Observational, Prospective, Multicenter Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
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.
Details
| Lead sponsor | Aesculap AG |
|---|---|
| Status | RECRUITING |
| Enrolment | 178 |
| Start date | 2026-04-10 |
| Completion | 2027-08 |
Conditions
- Subdural Hematoma
- Subdural Hematoma, Chronic
Interventions
- Histoacryl®
Primary outcomes
- Recurrence or progression of subdural hematoma — within 3 months
Recurrence will be described as maximum thickness of SDH exceeding 10 mm, recurrence of symptoms or the patient requiring reoperation, meaning a second burr-hole drainage due to SDH. \*\*Progression will be described as maximum thickness of SDH increasing over 3 mm compared to the baseline.
Countries
Japan