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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Multicenter Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
- ClinicalTrials.gov ID
- NCT07258069
- Acronym / sponsor ID
- HARMONY / AAG-O-H-25118
- Conditions
- Subdural Hematoma, Subdural Hematoma, Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histoacryl®Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes. | Device | – |
Primary outcome
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.
7 secondary outcomes
Efficacy (1. Time)
Time frame: V1, preoperatively (baseline visit)
Efficacy (2. Time)
Time frame: V2, surgery (index procedure)
Efficacy (3. Time)
Time frame: 6 months
Efficacy (4. Hematoma thickness)
Time frame: at V4: 3 months and V5: 6 months compared to baseline
Efficacy (5. Change in midlind shift)
Time frame: at V4: 3 months and V5: 6 months
Efficacy (6. Cognitive assessment)
Time frame: V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months
Quality of life, EQ-5D-5L
Time frame: V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subdural Hematoma and Subdural Hematoma, Chronic, run by Aesculap AG at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Soteras, Dr. (+34 935 8662 ext. 00, studies@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence or progression of subdural hematoma (time frame: within 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.