臨床研究等提出・公開システム

OBSERVATIONAL, PROSPECTIVE, MULTICENTER STUDY ON HISTOACRYL USED FOR EMBOLIZATION OF MIDDLE MENINGEAL ARTERY (MMA) IN CHRONIC SUBDURAL HEMATOMA (CSDH) (HARMONY study)

OBSERVATIONAL, PROSPECTIVE, MULTICENTER STUDY ON HISTOACRYL USED FOR EMBOLIZATION OF MIDDLE MENINGEAL ARTERY (MMA) IN CHRONIC SUBDURAL HEMATOMA (CSDH) (HARMONY study)

Sakai Chiaki

Kyoto University Hospital

53 Kawaramachi Shogoin, Sakyo-ku, Kyoto City

chiakisa@kuhp.kyoto-u.ac.jp

Chiaki Sakai

Kyoto University Hospital

53 Kawaramachi Shogoin, Sakyo-ku, Kyoto City

+81-75-751-3459

chiakisa@kuhp.kyoto-u.ac.jp

Pending

Feb. 16, 2026

Observational

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-18 years old or older
- Confirmed diagnosis of chronic subdural hematoma or recurrent subdural hematoma
- Completed documented informed consent
- Willingness and presumed capability to participate in follow-up visits for up to 6 months

- Extensive cerebral infarction, brain tumor, or space-occupying lesion requiring treatment
- Need craniotomy
- Any sign of anatomical variations that could make MMA embolization unsafe
- Coagulation dysfunction with INR>1.8 and/or platelet count <80*109/L
- Allergic reactions to Histoacryl and 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

Both

Chronic Subdural Hematoma

Chronic Subdural Hematoma

D020200

Recurrence or progression of subdural hematoma within 3 months following the index procedure

Efficacy
- Time period from symptoms to embolization, from burr-hole drainage to embolization and from embolization to recurrence
- Change in hematoma thickness at V4: 3 months and V5: 6 months compared to baseline
- Change in midline shift at V4: 3 months and V5: 6 months compared to baseline
- Cognitive assessment assessed by MMSE at V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months
- Quality of life assessed by EQ-5D scale from 0 (worst health) to 100 (best health) at V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months
Safety
- Rate of (Serious) Adverse Events at V3: discharge, V4: 3 months and V5: 6 months
- Duration of Hospital stay after index procedure
- Rate and duration of rehospitalization
Handling of Histoacryl
- Volume
- Targeted arteries (main trunk of MMA / frontal branches / parietal branches)
- Injection time
- Intraoperative complications/AEs (catheter breakage or entrapment, etc)

+81-75-366-7618

Yes

The collected data will be documented using the browser-based GCP-compliant Electronic Data Capture (EDC) system for collecting patient data in this clinical study. The platform for data collection will be provided by the sponsor. The investigator is responsible for all issues of data protection related to privacy protection and pseudonymization and for the accuracy and completeness of the data. Training will be recorded in the training log provided by the sponsor.

None