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NCT Number: NCT07258069

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kobe City Medical Center General Hospital, Kobe, Chuo-ku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Histoacryl®

Device

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

Primary outcomes

  1. Recurrence or progression of subdural hematoma

    Time frame: within 3 months

    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.

Secondary outcomes

  1. Efficacy (1. Time)

    Time frame: V1, preoperatively (baseline visit)

    Time period from symptoms to embolization

  2. Efficacy (2. Time)

    Time frame: V2, surgery (index procedure)

    Time period from burr-hole drainage to embolization

  3. Efficacy (3. Time)

    Time frame: 6 months

    Time period from embolization to recurrence

  4. Efficacy (4. Hematoma thickness)

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

    Change in hematoma thickness

  5. Efficacy (5. Change in midlind shift)

    Time frame: at V4: 3 months and V5: 6 months

    Change in midline shift compared to baseline

  6. Efficacy (6. Cognitive assessment)

    Time frame: V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months

    Mini-Mental State Examination (MMSE) from 0 (severe cognitive impairment) to 30 (no cognitive impairment)

  7. Quality of life, EQ-5D-5L

    Time frame: V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months

    assessed by EQ-5D scale from 0 (worst health) to 100 (best health)

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Soteras, Dr.

CONTACT

[email protected]

+34 935 8662 ext. 00

Yumiko Okaniva, Dr.

CONTACT

[email protected]

+81 3814 ext. 2525

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Acronym: HARMONY

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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