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RecruitingNCT07258069

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

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

Sponsor

Aesculap AG

Enrollment

178 participants

Start Date

Apr 10, 2026

Study Type

OBSERVATIONAL

Conditions

Subdural HematomaSubdural Hematoma, Chronic

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

DEVICEHistoacryl®

Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes.

Locations(7)

Kobe City Medical Center General Hospital

Kobe, Chuo-ku, Japan

Kokura Memorial Hospital

Fukuoka, Kitakyushu-city, Japan

Ohara HealthCare Foundation Kurashiki Central Hospital

Okayama, Kurashiki, Japan

Shimizu Hospital

Kyoto, Nishikyo-ku, Japan

National Hospital Organization Osaka National Hospital

Osaka-Fu, Osaka-shi, Japan

Kyoto University Hospital

Kyoto, Sakyo-ku, Japan

National Cerebral and Cardiovascular Center

Osaka, Suita, Japan

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NCT07258069

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