Endovascular TreatmentNCT06772740
Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma
A study testing Middle meningeal artery embolization in people with Endovascular Treatment and Chronic Subdural Hematoma, run by Kazutaka Uchida at 1 site in Japan.
Trial summary
COMPLEMENT study (ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to assess the efficacy and safety of middle meningeal artery embolization for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endovascular Treatment, Chronic Subdural Hematoma
- What is being tested?
- Middle meningeal artery embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteJapan
- Study dates
- 23 Dec 2024to 31 Mar 2029
- Phase
- Interventional
- 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
Who may be able to join
- Age >=18
- pre-mRS 0-3
- Hematoma thickness >=10mm
- Having at least one risk factor Risk factor: Age >=75, Antithrombotic therapy, DM, Bilateral hematoma, Markwalder grading score >3, Preoperative volume >=130ml, Preoperative midline shift >=8mm, CT appearance (Homogeneous, laminar or separated)
Who cannot join
- Cr >=1.8
- Plt <50,000, PT-INR >2
- Life expectancy <6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Hyogo Medical University
Nishinomiya, Hyōgo, 663-8501
Kazutaka Uchida, MD, PhD, +81-798-45-6458, fu-sakakibara@hyo-med.ac.jp
About this study
Official title: Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)
COMPLEMENT study (ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to assess the efficacy and safety of middle meningeal artery embolization for chronic subdural hematoma.
- Conditions
- Endovascular Treatment, Chronic Subdural Hematoma
- Being tested
- Middle meningeal artery embolization
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle meningeal artery embolizationProcedure or surgery
Middle meningeal artery embolization within 7 days after randomization
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatments with middle meningeal artery embolization | Experimental | Not described Receives: Procedure: Middle meningeal artery embolization |
| Conventional treatments alone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence of chronic subdural hematoma
Recurrence of chronic subdural hematoma is defined as the maximum thickness of subdural hematoma exceeding 10 mm or the patient receiving re-operation.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start23 Dec 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular TreatmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kazutaka Uchida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kazutaka Uchida, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772740
- Sponsor's protocol ID
- R000063204
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)
- ClinicalTrials.gov ID
- NCT06772740
- Acronym / sponsor ID
- R000063204
- Conditions
- Endovascular Treatment, Chronic Subdural Hematoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kazutaka UchidaUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 14 Jan 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.
COMPLEMENT study (ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to assess the efficacy and safety of middle meningeal artery embolization for chronic subdural hematoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatments with middle meningeal artery embolization | Experimental | Procedure: Middle meningeal artery embolization |
| Conventional treatments alone | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >=18
- pre-mRS 0-3
- Hematoma thickness >=10mm
- Having at least one risk factor Risk factor: Age >=75, Antithrombotic therapy, DM, Bilateral hematoma, Markwalder grading score >3, Preoperative volume >=130ml, Preoperative midline shift >=8mm, CT appearance (Homogeneous, laminar or separated)
Key exclusion criteria (3 listed)
- Cr >=1.8
- Plt <50,000, PT-INR >2
- Life expectancy <6 months
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 |
|---|---|---|
| Middle meningeal artery embolizationMiddle meningeal artery embolization within 7 days after randomization | Procedure or surgery | Conventional treatments with middle meningeal artery embolization |
Primary outcome
Rate of recurrence of chronic subdural hematoma
Time frame: 6 months after randomization
Recurrence of chronic subdural hematoma is defined as the maximum thickness of subdural hematoma exceeding 10 mm or the patient receiving re-operation.
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 17 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Middle meningeal artery embolization in people with Endovascular Treatment and Chronic Subdural Hematoma, run by Kazutaka Uchida at 1 site 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 3 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Kazutaka Uchida, MD, PhD (81+798-45-6458, fu-sakakibara@hyo-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrence of chronic subdural hematoma (time frame: 6 months after randomization). 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 17 Jul 2026.