Actively Recruiting
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
Led by Aesculap AG · Updated on 2026-04-17
178
Participants Needed
7
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- Extensive cerebral infarction, brain tumor, or space-occupying lesion requiring treatment
- Need for craniotomy
- Signs of anatomical variations that make MMA embolization unsafe (e.g., prominent MMA-opthalmic artery anastomoses)
- Coagulation dysfunction with INR > 1.8 and/or platelet count < 80 x 10^9 /L
- Allergic reactions to essential medicines used for angiography
- Women who are pregnant, lactating, or of childbearing age planning pregnancy during the study
- Participation in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Kobe City Medical Center General Hospital
Kobe, Chuo-ku, Japan, 〒650-0047
Not Yet Recruiting
2
Kokura Memorial Hospital
Fukuoka, Kitakyushu-city, Japan, 〒802-8555
Not Yet Recruiting
3
Ohara HealthCare Foundation Kurashiki Central Hospital
Okayama, Kurashiki, Japan, 〒710-8602
Not Yet Recruiting
4
Shimizu Hospital
Kyoto, Nishikyo-ku, Japan, 〒615-8237
Actively Recruiting
5
National Hospital Organization Osaka National Hospital
Osaka-Fu, Osaka-shi, Japan, 〒540-0006
Not Yet Recruiting
6
Kyoto University Hospital
Kyoto, Sakyo-ku, Japan, 〒606-8507
Not Yet Recruiting
7
National Cerebral and Cardiovascular Center
Osaka, Suita, Japan, 〒564-8565
Not Yet Recruiting
Research Team
M
Marta Soteras, Dr.
CONTACT
Y
Yumiko Okaniva, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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