Chronic Subdural Hemorrhage (cSDH)SEEDNCT07291427
Chronic Subdural Hematoma Embolization With Detachable Coils
An observational study of Chronic Subdural Hemorrhage (cSDH), run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
Trial summary
This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hemorrhage (cSDH)
- What is being tested?
- Balt coils: (Balt USA, LLC) and MMA embolization
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Jun 2026to 1 Sep 2028
- How long will I take part?
- 180 Days
- 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 symptomatic chronic subdural hematoma (cSDH), with or without previous surgical evacuation that need additional treatment
Who may be able to join
- Age ≥ 18
- Patients experiencing unilateral or bilateral non-acute subdural hematoma confirmed by CT imaging. Acute on Chronic or mixed density hematoma allowed.
- A clinical decision has been made to use coiling and/or embolics as treatment, with or without surgical debridement, independently as per standard of care and prior to enrollment in the study.
- Signed informed consent obtained by patient or Legal Authorized Representative (LAR)
Who cannot join
- Primary acute SDH
- Prior MMAE in target territory
- Premorbid mRS > 3
- Common carotid stenosis >70% or prior carotid stent placement
- Significant medical contraindication to angiography (kidney failure/disease)
- Anatomical variations that would make MMA embolization difficult or unsafe
Show all 9Show fewer
- Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints
- Pregnancy
- Life expectancy ≤ 1 year
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
University of Louisville
Louisville, Kentucky, 40292
Mechelle Kaufman, Mechelle.Kaufman@louisville.edu
Isaac Josh Abecassis, MD
- Not yet recruiting
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Michael Omimi, Michael-Omini@OU.edu
Hakeem Shakir, MD
- Not yet recruiting
University of California - San Deigo
San Deigo, California, 92093
Pete Chase, PChase@Health.UCSD.edu
David Santiago-Dieppa, MD
- Not yet recruiting
Carondelet Neurological Institute
Tucson, Arizona, 85711
Matthew Pohlmeyer, Matthew.Pohlmeyer@tenethealth.org
Alexander Coon, MD
- Recruiting
John Muir Health
Walnut Creek, California, 94598
Melenie Aaron, Melenie.Aaron@JohnMuirHealth.com
Benjamin Yim, MD
About this study
Official title: Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils
This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH).
Read the detailed description
The primary objective of this observational registry study is to assess the safety and efficacy of Balt Coils as an adjunct to middle meningeal artery (MMA) embolization in a real-world setting among patients undergoing treatment for chronic subdural hematoma (cSDH), and explore correlations between patient characteristics, clinical characteristics, and outcomes. By collecting comprehensive, real-world data, the registry will characterize procedural inputs, document clinical and radiographic outcomes, and explore variation in technique and practice setting. The overarching goal is to generate a more complete understanding of Middle Meningeal Artery Embolization (MMAE) in diverse clinical environments, inform future prospective studies, and guide evidence-based adoption of this evolving therapy. Patients may be treated with Balt coils regardless of enrollment in the study as the decision to place the coils should be made independently as per standard of care and prior to enrollment in the study.
- Conditions
- Chronic Subdural Hemorrhage (cSDH)
- Being tested
- Balt coils: (Balt USA, LLC), MMA embolization
- Keywords
- Subdural hemorrhage, Coils, Middle meningeal artery
- Medical subject headings
- Hematoma, Subdural, Chronic, Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balt coils: (Balt USA, LLC)Device
Also called Optima, OptiMax, OptiBlock, Optima series line extensions
MMA embolization utilizing Balt Coils
MMA embolizationProcedure or surgery
surgical or bedside evacuation
pre or post-surgical debridement
| Study group | Role | What they receive |
|---|---|---|
| Participants with cSDH | All participants enrolled will be treated with the Balt coils.
1. MMA embolization: Utilize Balt Coils as stand-alone with or without other embolics treatment.
2. MMA embolization: Utilize Balt Coils in combination with or without embolics in surgical or bedside evacuation, such as:
1. MMA embolization in combination with Balt coils post-surgical debridement, or
2. MMA embolization using Balt coils alone, pre- or post-surgical debridement. Receives: Device: Balt coils: (Balt USA, LLC); Procedure: MMA embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hematoma volume
Change in hematoma volume based on CT imaging
Measured: 180 days
Change in maximal thickness
Change in maximal thickness based on CT imaging
Measured: 180 days
Change in midline shift
Change in midline shift (mm) based on CT imaging
Measured: 180 days
Number of periprocedural major disabling stroke or any death
Number of periprocedural major disabling stroke or any death
Measured: 30 days
Number of participants with symptomatic recurrence progression requiring retreatment
Number of participants with symptomatic recurrence progression of the SDH requiring retreatment
Measured: 180 days
Secondary outcomes (3)
Number of Device-related adverse events (AE), serious adverse events (SAE), and procedural-related SAE
Number of Adverse events and serious adverse events related to the device as assessed by an independent medical monitor
Measured: 180 days
Number of Acute successful embolization of the target vessel
Determination of successful embolization based on angiographic imaging
Measured: Immediately post-procedure
Change in EuroQoL 5 dimensions 5 levels (EQ-5D-5L)
The EQ-5D is a generic instrument for describing and valuing health. The new version includes the 5 levels of severity in each of the existing five EQ-5D dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and now called the EQ-5D-5L, each assessed on a 5-point scale (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). Participants score each dimension based on their health that day and their responses are used to generate a health index score. Index scores could range from <0 (a health state equivalent to dead with negative values representing a state worse than dead) to 1 (full health). Lower scores indicate a higher QoL.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start2 Jun 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural Hemorrhage (cSDH)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 180 Days
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- John Muir Health, Carondelet Neurological Institute, Balt USA
- Responsible party
- Principal investigator, Christopher P Kellner, Icahn School of Medicine at Mount Sinai
- Investigators
- Christopher Kellner, Principal investigator, Icahn School of Medicine at Mount SinaiBenjamin Yim, Principal investigator, John Muir HealthAlexander Coon, Principal investigator, Carondelet Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291427
- Sponsor's protocol ID
- STUDY-25-01365
- Acronym
- SEED
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Upon the completion of the study, Mount Sinai's data management team will clean and analyze all data in preparation of manuscript writing and publication. Data that will be shared and published will be that of all participants combined to protect individual patient privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils
- ClinicalTrials.gov ID
- NCT07291427
- Acronym / sponsor ID
- SEED / STUDY-25-01365
- Conditions
- Chronic Subdural Hemorrhage (cSDH)
- Keywords
- Subdural hemorrhage, Coils, Middle meningeal artery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- John Muir Health, Carondelet Neurological Institute, Balt USA
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 18 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.
This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH).
Detailed description
The primary objective of this observational registry study is to assess the safety and efficacy of Balt Coils as an adjunct to middle meningeal artery (MMA) embolization in a real-world setting among patients undergoing treatment for chronic subdural hematoma (cSDH), and explore correlations between patient characteristics, clinical characteristics, and outcomes. By collecting comprehensive, real-world data, the registry will characterize procedural inputs, document clinical and radiographic outcomes, and explore variation in technique and practice setting. The overarching goal is to generate a more complete understanding of Middle Meningeal Artery Embolization (MMAE) in diverse clinical environments, inform future prospective studies, and guide evidence-based adoption of this evolving therapy. Patients may be treated with Balt coils regardless of enrollment in the study as the decision to place the coils should be made independently as per standard of care and prior to enrollment in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 180 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with cSDH | – | Device: Balt coils: (Balt USA, LLC), Procedure: MMA embolizationAll participants enrolled will be treated with the Balt coils. 1. MMA embolization: Utilize Balt Coils as stand-alone with or without other embolics treatment. 2. MMA embolization: Utilize Balt Coils in combination with or without embolics in surgical or bedside evacuation, such as: 1. MMA embolization in combination with Balt coils post-surgical debridement, or 2. MMA embolization using Balt coils alone, pre- or post-surgical debridement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic chronic subdural hematoma (cSDH), with or without previous surgical evacuation that need additional treatment
Key inclusion criteria (4 listed)
- Age ≥ 18
- Patients experiencing unilateral or bilateral non-acute subdural hematoma confirmed by CT imaging. Acute on Chronic or mixed density hematoma allowed.
- A clinical decision has been made to use coiling and/or embolics as treatment, with or without surgical debridement, independently as per standard of care and prior to enrollment in the study.
- Signed informed consent obtained by patient or Legal Authorized Representative (LAR)
Key exclusion criteria (9 listed)
- Primary acute SDH
- Prior MMAE in target territory
- Premorbid mRS > 3
- Common carotid stenosis >70% or prior carotid stent placement
- Significant medical contraindication to angiography (kidney failure/disease)
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 |
|---|---|---|
| Balt coils: (Balt USA, LLC)Also: Optima, OptiMax, OptiBlock, Optima series line extensionsMMA embolization utilizing Balt Coils | Device | Participants with cSDH |
| MMA embolizationsurgical or bedside evacuation pre or post-surgical debridement | Procedure or surgery | Participants with cSDH |
Primary outcome
Change in hematoma volume
Time frame: 180 days
Change in hematoma volume based on CT imaging
Change in maximal thickness
Time frame: 180 days
Change in maximal thickness based on CT imaging
Change in midline shift
Time frame: 180 days
Change in midline shift (mm) based on CT imaging
Number of periprocedural major disabling stroke or any death
Time frame: 30 days
Number of periprocedural major disabling stroke or any death
Number of participants with symptomatic recurrence progression requiring retreatment
Time frame: 180 days
Number of participants with symptomatic recurrence progression of the SDH requiring retreatment
3 secondary outcomes
Number of Device-related adverse events (AE), serious adverse events (SAE), and procedural-related SAE
Time frame: 180 days
Number of Acute successful embolization of the target vessel
Time frame: Immediately post-procedure
Change in EuroQoL 5 dimensions 5 levels (EQ-5D-5L)
Time frame: 180 days
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 25 Sep 2026.
- Individual participant dataSharing planned: No. Upon the completion of the study, Mount Sinai's data management team will clean and analyze all data in preparation of manuscript writing and publication. Data that will be shared and published will be that of all participants combined to protect individual patient privacy and confidentiality.
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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.
Christopher Kellner principal investigator
Icahn School of Medicine at Mount Sinai
Benjamin Yim principal investigator
John Muir Health
Alexander Coon principal investigator
Carondelet Neurological Institute
5 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 Hemorrhage (cSDH), run by Icahn School of Medicine at Mount Sinai at 5 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 4 inclusion and 9 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Sukaina Davdani ((212) 241-2524, Sukaina.Davdani@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hematoma volume (time frame: 180 days). The study lists 5 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 25 Sep 2026.