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
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)
View Full Details on ClinicalTrials.gov
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NCT07258069