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NCT Number: 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

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.

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Key information

Conditions

Chronic Subdural Hematoma Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Chronic Subdural Hematomas Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries cSDH

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westchester Medical Center, Valhalla, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuro endovascular embolic coil

Device

i-ED COIL, Kaneka Corporation

Other names: Embolization coil

Primary outcomes

  1. Effectiveness

    Time frame: 6 months

    Incidence of hematoma recurrence or progression requiring repeat embolization within 180 days

  2. Safety

    Time frame: 90 days

    Modified rankin scale at 90 days post procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Leah Lyons, PA

CONTACT

[email protected]

212-705-4340

Yuki Arimoto

CONTACT

[email protected]

212-705-4340

Sponsors and collaborators

Lead sponsor

Kaneka Medical America LLC

Industry

Registry information

Official study title

i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study

Acronym: iCURE cSDH

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 9, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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