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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
Sponsor: Kaneka Medical America LLC
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.
Official title: i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2025-11-30
Completion Date
2027-05-31
Last Updated
2025-10-09
Healthy Volunteers
No
Interventions
Neuro endovascular embolic coil
i-ED COIL, Kaneka Corporation
Locations (2)
Westchester Medical Center
Valhalla, New York, United States
University of Pennslyvania
Philadelphia, Pennsylvania, United States