Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Histoacryl®
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov