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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07214623

Acronym

iCURE cSDH

Enrollment

200

Registered

2025-10-09

Start date

2025-11-30

Completion date

2027-05-31

Last updated

2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Subdural Hematoma, Chronic Subdural Hematomas, cSDH

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.

Interventions

DEVICENeuro endovascular embolic coil

i-ED COIL, Kaneka Corporation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactYuki Arimoto

yuki.arimoto@kaneka.com212-705-4340

Backup ContactLeah Lyons, PA

leah.lyons@kaneka.com212-705-4340

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026