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NOT YET RECRUITING
NCT07214623

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

View on ClinicalTrials.gov

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

DEVICE

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