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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

NCT07214623 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-10-09

No results posted yet for this study

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.

Conditions

  • Chronic Subdural Hematoma
  • cSDH
  • Chronic Subdural Hematomas

Interventions

DEVICE

Neuro endovascular embolic coil

i-ED COIL, Kaneka Corporation

Sponsors & Collaborators

  • Kaneka Medical America LLC

    lead INDUSTRY

Principal Investigators

  • Fawaz Al-Mufti, MD · Westchester Medical Center

  • Jan-Karl Burkhardt, MD · University of Pennsylvania

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2026-11-30
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07214623 on ClinicalTrials.gov