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Recruiting NCT07258069

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

Conditions: Subdural Hematoma Subdural Hematoma, Chronic

Sponsor: Aesculap AG

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Histoacryl®
DEVICE
Locations 7
Japan (7)
Kokura Memorial Hospital
Fukuoka , Kitakyushu-city
NOT_YET_RECRUITING
Taketo Hatano, Dr.
Kobe City Medical Center General Hospital
Kobe , Chuo-ku
NOT_YET_RECRUITING
Hirotoshi Imamura, Dr.
Shimizu Hospital
Kyoto , Nishikyo-ku
Nobuyuki Sakai, Dr.
Kyoto University Hospital
Kyoto , Sakyo-ku
NOT_YET_RECRUITING
Chiaki Sakai, Dr.
Ohara HealthCare Foundation Kurashiki Central Hospital
Okayama , Kurashiki
NOT_YET_RECRUITING
Masanori Kinosada, Dr.
National Cerebral and Cardiovascular Center
Osaka , Suita
NOT_YET_RECRUITING
Masakazu Okawa, Dr.
National Hospital Organization Osaka National Hospital
Osaka-Fu , Osaka-shi
NOT_YET_RECRUITING
Toshiyuki Fujinaka, Dr.
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.04.2026
Completion date
01.08.2027
Registry ID
NCT07258069
Source
clinicaltrials.gov
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