Histoacryl glue embolization of the middle meningeal artery for chronic subdural hematoma (HARMONY)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults with chronic or recurrent subdural hematoma who undergo embolization of the middle meningeal artery using Histoacryl (a medical glue). Participants are recruited at three Japanese hospitals and are followed clinically and with imaging for up to six months to record recurrence or progression. Key eligibility excludes patients who need immediate craniotomy, have unsafe vascular anatomy for embolization, significant coagulopathy, or pregnancy. Data will be collected on safety, radiographic outcomes, and any need for additional surgical treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Shimizu Hospital
  Kyoto, Nishikyo-ku, Japan Recruiting
• National Hospital Organization Osaka National Hospital
  Osaka-Fu, Osaka-shi, Japan Recruiting
• Kyoto University Hospital
  Kyoto, Sakyo-ku, Japan Recruiting
• Kokura Memorial Hospital
  Fukuoka, Kitakyushu-city, Japan Not yet recruiting
• Ohara HealthCare Foundation Kurashiki Central Hospital
  Okayama, Kurashiki, Japan Not yet recruiting
• National Cerebral and Cardiovascular Center
  Osaka, Suita, Japan Not yet recruiting

Study contacts

• Study coordinator: Marta Soteras, Dr.
• Email: studies@aesculap.de
• Phone: +34 935 8662

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.