Observational, Prospective, Multicenter Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Japan
Kokura Memorial Hospital
NOT_YET_RECRUITING
Fukuoka
Kobe City Medical Center General Hospital
NOT_YET_RECRUITING
Kobe
Kyoto University Hospital
NOT_YET_RECRUITING
Kyoto
Shimizu Hospital
RECRUITING
Kyoto
Ohara HealthCare Foundation Kurashiki Central Hospital
NOT_YET_RECRUITING
Okayama
National Cerebral and Cardiovascular Center
NOT_YET_RECRUITING
Osaka
National Hospital Organization Osaka National Hospital
NOT_YET_RECRUITING
Osaka-fu
Contact Information
Primary
Marta Soteras, Dr.
studies@aesculap.de
+34 935 8662
Backup
Yumiko Okaniva, Dr.
gen.jp@bbraun.jp
+81 3814
Time Frame
Start Date: 2026-04-10
Estimated Completion Date: 2027-08
Participants
Target number of participants: 178
Related Therapeutic Areas
Sponsors
Leads: Aesculap AG