Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
NCT ID: NCT07258069
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
178 participants
OBSERVATIONAL
2025-12-31
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Histoacryl®
Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Aesculap AG
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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AAG-O-H-25118
Identifier Type: -
Identifier Source: org_study_id
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