Chronic Subdural Hematoma Embolization With Detachable Coils
NCT07291427 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150
Last updated 2026-03-10
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).
Conditions
- Chronic Subdural Hemorrhage (cSDH)
Interventions
- DEVICE
-
Balt coils: (Balt USA, LLC)
MMA embolization utilizing Balt Coils
- PROCEDURE
-
MMA embolization
surgical or bedside evacuation pre or post-surgical debridement
Sponsors & Collaborators
-
John Muir Health
collaborator OTHER -
Carondelet Neurological Institute
collaborator UNKNOWN -
Icahn School of Medicine at Mount Sinai
lead OTHER
Principal Investigators
-
Christopher Kellner · Icahn School of Medicine at Mount Sinai
-
Benjamin Yim · John Muir Health
-
Alexander Coon · Carondelet Neurological Institute
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2028-09-01
- Completion
- 2028-09-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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