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

Not yet recruiting

• Conditions: Chronic Subdural Hematoma; cSDH; Chronic Subdural Hematomas

• Registration Number: NCT07214623
• Lead Sponsor: Kaneka Medical America LLC

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 have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2025-11-30
• Primary Completion: 2026-11-30
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness	6 months	Incidence of hematoma recurrence or progression requiring repeat embolization within 180 days
Safety	90 days	Modified rankin scale at 90 days post procedure

Trial Locations

Locations (2)

Westchester Medical Center; 🇺🇸 Valhalla, New York, United States

University of Pennslyvania; 🇺🇸 Philadelphia, Pennsylvania, United States