NCT07214623

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Nov 2025May 2027

First Submitted

Initial submission to the registry

October 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

1 year

First QC Date

October 2, 2025

Last Update Submit

October 2, 2025

Conditions

Chronic Subdural HematomacSDHChronic Subdural Hematomas

Outcome Measures

Primary Outcomes (2)

  • Effectiveness

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

    6 months

  • Safety

    Modified rankin scale at 90 days post procedure

    90 days

Interventions

Neuro endovascular embolic coilDEVICE

i-ED COIL, Kaneka Corporation

Also known as: Embolization coil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic subdural hematomas with symptoms

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

University of Pennslyvania

Philadelphia, Pennsylvania, 11104, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, SubduralIntracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematomaHemorrhageWounds and Injuries

Study Officials

  • Fawaz Al-Mufti, MD

    Westchester Medical Center

    PRINCIPAL INVESTIGATOR

  • Jan-Karl Burkhardt, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuki Arimoto

CONTACT

212-705-4340yuki.arimoto@kaneka.com

Leah Lyons, PA

CONTACT

212-705-4340leah.lyons@kaneka.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2025

First Posted

October 9, 2025

Study Start

November 30, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

October 9, 2025

Record last verified: 2025-10

Locations

US(2)