NCT07291427 Chronic Subdural Hematoma Embolization With Detachable Coils
| NCT ID | NCT07291427 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Chronic Subdural Hemorrhage (cSDH) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-06-02 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion criteria: * 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) Exclusion criteria: * 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 * Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints * Pregnancy * Life expectancy ≤ 1 year
Contact & Investigator
Christopher Kellner
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT07291427 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Subdural Hemorrhage (cSDH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07291427 currently recruiting?
Yes, NCT07291427 is actively recruiting participants. Contact the research team at Sukaina.Davdani@mountsinai.org for enrollment information.
Where is the NCT07291427 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07291427 clinical trial?
NCT07291427 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Christopher Kellner at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 150 participants.