Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)

NCT07258069 | Recruiting

• 1 other identifier: AAG-O-H-25118
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Subdural Hematoma; Subdural Hematoma, Chronic

Outcome Measures

Primary Outcomes (1)

• Recurrence or progression of subdural hematoma

  Recurrence will be described as maximum thickness of SDH exceeding 10 mm, recurrence of symptoms or the patient requiring reoperation, meaning a second burr-hole drainage due to SDH. \*\*Progression will be described as maximum thickness of SDH increasing over 3 mm compared to the baseline.

  within 3 months

Secondary Outcomes (7)

• Efficacy (1. Time)

  V1, preoperatively (baseline visit)

• Efficacy (2. Time)

  V2, surgery (index procedure)

• Efficacy (3. Time)

  6 months

• Efficacy (4. Hematoma thickness)

  at V4: 3 months and V5: 6 months compared to baseline

• Efficacy (5. Change in midlind shift)

  at V4: 3 months and V5: 6 months

Interventions

Histoacryl® DEVICE

Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (7)

Kobe City Medical Center General Hospital

Kobe, Chuo-ku, 〒650-0047, Japan

NOT YET RECRUITING

Kokura Memorial Hospital

Fukuoka, Kitakyushu-city, 〒802-8555, Japan

NOT YET RECRUITING

Ohara HealthCare Foundation Kurashiki Central Hospital

Okayama, Kurashiki, 〒710-8602, Japan

NOT YET RECRUITING

Shimizu Hospital

Kyoto, Nishikyo-ku, 〒615-8237, Japan

RECRUITING

National Hospital Organization Osaka National Hospital

Osaka-Fu, Osaka-shi, 〒540-0006, Japan

NOT YET RECRUITING

Kyoto University Hospital

Kyoto, Sakyo-ku, 〒606-8507, Japan

NOT YET RECRUITING

National Cerebral and Cardiovascular Center

Osaka, Suita, 〒564-8565, Japan

NOT YET RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural; Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Chronic Disease; Disease Attributes

Central Study Contacts

Marta Soteras, Dr.

CONTACT

+34 935 8662; studies@aesculap.de

Yumiko Okaniva, Dr.

CONTACT

+81 3814; gen.jp@bbraun.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7)