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

Starting soon

Conditions studied: Chronic Subdural Hematoma, cSDH, Chronic Subdural Hematomas

In brief

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.

Key facts

Study ID

NCT07214623

Run by

Kaneka Medical America LLC

People needed

200

Starts

2025-11-30

Expected to finish

2027-05-31

Last updated by the study team

2025-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pre morbid mRS 0-3
• Chronic subdural symptomatic, requiring intervention

You may not qualify if…

• Acute subdural hematoma
• Intercranial mass other than subdural hematoma
• Females pregnant or breast feeding
• Compromised survival or inability to complete trial

Where it is running

• Westchester Medical Center — Valhalla, New York, United States
• University of Pennslyvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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