Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Kaneka Medical America LLC
Conditions:
Chronic Subdural Hematoma
cSDH
Eligibility:
All Genders
18+ years
Brief 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 h...
Eligibility Criteria
Inclusion
- Pre morbid mRS 0-3
- Chronic subdural symptomatic, requiring intervention
Exclusion
- Acute subdural hematoma
- Intercranial mass other than subdural hematoma
- Females pregnant or breast feeding
- Compromised survival or inability to complete trial
Key Trial Info
Start Date :
November 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07214623
Start Date
November 30 2025
End Date
May 31 2027
Last Update
October 9 2025
Active Locations (2)
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1
Westchester Medical Center
Valhalla, New York, United States, 10595
2
University of Pennslyvania
Philadelphia, Pennsylvania, United States, 11104