Chronic Subdural HematomaiCURE cSDHNCT07214623
Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy
An observational study of Chronic Subdural Hematoma and cSDH, run by Kaneka Medical America LLC at 2 sites in United States.
Trial summary
All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, cSDH, Chronic Subdural Hematomas
- What is being tested?
- Neuro endovascular embolic coil
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2025to 31 May 2027
- How long will I take part?
- 6 Months
- 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: Patients with chronic subdural hematomas with symptoms
Who may be able to join
- Pre morbid mRS 0-3
- Chronic subdural symptomatic, requiring intervention
Who cannot join
- Acute subdural hematoma
- Intercranial mass other than subdural hematoma
- Females pregnant or breast feeding
- Compromised survival or inability to complete trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Pennslyvania
Philadelphia, Pennsylvania, 11104
Jan-Karl Burkhardt, MD, 917-597-9435, jan.burkhardt@pennmedicine.upenn.edu
Jan-Karl Burkhardt, MD
Westchester Medical Center
Valhalla, New York, 10595
Fawaz Al-Mufti, MD, 914-493-5098, fawaz.al-mufti@wmchealth.org
Fawaz Al-Mufti, MD
About this study
Official title: i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study
All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.
- Conditions
- Chronic Subdural Hematoma, cSDH, Chronic Subdural Hematomas
- Being tested
- Neuro endovascular embolic coil
- 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.
Neuro endovascular embolic coilDevice
Also called Embolization coil
i-ED COIL, Kaneka Corporation
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Incidence of hematoma recurrence or progression requiring repeat embolization within 180 days
Measured: 6 months
Safety
Modified rankin scale at 90 days post procedure
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kaneka Medical America LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fawaz Al-Mufti, MD, Principal investigator, Westchester Medical CenterJan-Karl Burkhardt, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214623
- Sponsor's protocol ID
- CLIN-002
- Acronym
- iCURE cSDH
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study
- ClinicalTrials.gov ID
- NCT07214623
- Acronym / sponsor ID
- iCURE cSDH / CLIN-002
- Conditions
- Chronic Subdural Hematoma, cSDH, Chronic Subdural Hematomas
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kaneka Medical America LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Oct 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.
All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic subdural hematomas with symptoms
Key inclusion criteria (2 listed)
- Pre morbid mRS 0-3
- Chronic subdural symptomatic, requiring intervention
Key exclusion criteria (4 listed)
- Acute subdural hematoma
- Intercranial mass other than subdural hematoma
- Females pregnant or breast feeding
- Compromised survival or inability to complete trial
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 |
|---|---|---|
| Neuro endovascular embolic coilAlso: Embolization coili-ED COIL, Kaneka Corporation | Device | – |
Primary outcome
Effectiveness
Time frame: 6 months
Incidence of hematoma recurrence or progression requiring repeat embolization within 180 days
Safety
Time frame: 90 days
Modified rankin scale at 90 days post procedure
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 2025.
- Individual participant dataSharing planned: Undecided
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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.
Fawaz Al-Mufti, MD principal investigator
Westchester Medical Center
Jan-Karl Burkhardt, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Subdural Hematoma and cSDH, run by Kaneka Medical America LLC at 2 sites in United States.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Yuki Arimoto (212-705-4340, yuki.arimoto@kaneka.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 6 months). The study lists 2 primary outcomes in all. 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 2025.