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Набира участници NCT07258069

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

Заболявания: Subdural Hematoma Subdural Hematoma, Chronic

Спонсор: Aesculap AG

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
Histoacryl®
DEVICE
Места на провеждане 7
Япония (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.
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
10.04.2026
Крайна дата
01.08.2027
Регистрационен номер
NCT07258069
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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