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

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.

NCT Number	NCT07214623
Lead Sponsor	Kaneka Medical America LLC
Conditions	Chronic Subdural Hematoma, cSDH, Chronic Subdural Hematomas
Enrollment	200 participants
Start Date	2025-11-30
Primary Completion	2026-11-30 (estimated)
Study Completion	2027-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-10-09