Subdural HematomaHARMONYNCT07258069
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
An observational study of Subdural Hematoma and Subdural Hematoma, Chronic, run by Aesculap AG at 6 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subdural Hematoma, Subdural Hematoma, Chronic
- What is being tested?
- Histoacryl®
- Type of treatment
- Medical device
- How many people
- 178 participants
- Where
- 6 sitesJapan
- Study dates
- 10 Apr 2026to Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Japan6 sites, 6 recruiting
- Not yet recruiting
Kokura Memorial Hospital
Fukuoka, Kitakyushu-city, 〒802-8555
Taketo Hatano, Dr., 093-511-2000
- Recruiting
Shimizu Hospital
Kyoto, Nishikyo-ku, 〒615-8237
Nobuyuki Sakai, Dr., 075-381-5161
- Recruiting
Kyoto University Hospital
Kyoto, Sakyo-ku, 〒606-8507
Chiaki Sakai, Dr., 0570-030 ext. 311
- Not yet recruiting
Ohara HealthCare Foundation Kurashiki Central Hospital
Okayama, Kurashiki, 〒710-8602
Masanori Kinosada, Dr., 086-422-0210
- Not yet recruiting
National Cerebral and Cardiovascular Center
Osaka, Suita, 〒564-8565
Masakazu Okawa, Dr., 0570-012-545
- Recruiting
National Hospital Organization Osaka National Hospital
Osaka-Fu, Osaka-shi, 〒540-0006
Toshiyuki Fujinaka, Dr., 06-6942-1331
About this study
Official title: Observational, Prospective, Multicenter 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.
- Conditions
- Subdural Hematoma, Subdural Hematoma, Chronic
- Being tested
- Histoacryl®
- Medical subject headings
- Hematoma, Subdural, Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histoacryl®Device
Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 3 months
Secondary outcomes (7)
Efficacy (1. Time)
Time period from symptoms to embolization
Measured: V1, preoperatively (baseline visit)
Efficacy (2. Time)
Time period from burr-hole drainage to embolization
Measured: V2, surgery (index procedure)
Efficacy (3. Time)
Time period from embolization to recurrence
Measured: 6 months
Efficacy (4. Hematoma thickness)
Change in hematoma thickness
Measured: at V4: 3 months and V5: 6 months compared to baseline
Efficacy (5. Change in midlind shift)
Change in midline shift compared to baseline
Measured: at V4: 3 months and V5: 6 months
Efficacy (6. Cognitive assessment)
Mini-Mental State Examination (MMSE) from 0 (severe cognitive impairment) to 30 (no cognitive impairment)
Measured: V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months
Quality of life, EQ-5D-5L
assessed by EQ-5D scale from 0 (worst health) to 100 (best health)
Measured: V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start10 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258069
- Sponsor's protocol ID
- AAG-O-H-25118
- Acronym
- HARMONY
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No