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

Part of paid clinical trials in Valhalla, New York.

Sponsor
Kaneka Medical America LLC
Study ID
NCT07214623
Status
Not Yet Recruiting

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Conditions

  • Chronic Subdural Hematoma
  • Chronic Subdural Hematomas
  • cSDH

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neuro endovascular embolic coil — DEVICE
    i-ED COIL, Kaneka Corporation

Study Details

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 Dates

Start date
Nov 30, 2025
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Effectiveness [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Westchester Medical CenterValhallaNew York10595
Fawaz Al-Mufti, MD
[email protected]
914-493-5098
Fawaz Al-Mufti, MD (PRINCIPAL_INVESTIGATOR)
University of PennslyvaniaPhiladelphiaPennsylvania11104
Jan-Karl Burkhardt, MD
[email protected]
917-597-9435
Jan-Karl Burkhardt, MD (PRINCIPAL_INVESTIGATOR)

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Westchester Medical Center· Valhalla, NYUniversity of Pennslyvania· Philadelphia, PA

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