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Not yet recruitingNCT07214623iCURE cSDHUpdated Oct 9, 2025

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

An observational study in Chronic Subdural Hematoma, cSDH and Chronic Subdural Hematomas, sponsored by Kaneka Medical America LLC. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-09.

Sponsored by Kaneka Medical America LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

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.

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Conditions studied

  • Chronic Subdural Hematoma
  • cSDH
  • Chronic Subdural Hematomas
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In context

Hematoma, Subdural, Chronic

114 studies on the registry are indexed under Hematoma, Subdural, Chronic; 48 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 21 observational studies indexed under Hematoma, Subdural, Chronic.

Browse Hematoma, Subdural, Chronic studies →

Lead sponsor

Kaneka Medical America LLC is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with chronic subdural hematomas with symptoms

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Acute subdural hematoma
  • Intercranial mass other than subdural hematoma
  • Females pregnant or breast feeding
  • Compromised survival or inability to complete trial
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Interventions

  • DeviceNeuro endovascular embolic coil

    i-ED COIL, Kaneka Corporation

    Also known as: Embolization coil

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What researchers measure

Primary outcomes

  1. Effectiveness

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

    Time frame: 6 months

  2. Safety

    Modified rankin scale at 90 days post procedure

    Time frame: 90 days

07

Study locations

2 sites
  • Westchester Medical Center
    Valhalla, New York 10595, United States
  • University of Pennslyvania
    Philadelphia, Pennsylvania 11104, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07214623
Lead sponsor
Kaneka Medical America LLC
Responsible party
Sponsor
First posted
Oct 9, 2025
Start date
Nov 30, 2025 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Oct 9, 2025

Study contacts

Yuki Arimoto
Contact
yuki.arimoto@kaneka.com
212-705-4340
Leah Lyons, PA
Contact
leah.lyons@kaneka.com
212-705-4340
Fawaz Al-Mufti, MD
principal investigator · Westchester Medical Center
Jan-Karl Burkhardt, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Kaneka Medical America LLC

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