Menu
Not yet recruiting 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

— Observational Chronic Subdural Hematoma cSDH Chronic Subdural Hematomas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuro endovascular embolic coil.
Who it may be relevant to
Registry conditions: Chronic Subdural Hematoma, cSDH, Chronic Subdural Hematomas. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device Neuro endovascular embolic coil
    i-ED COIL, Kaneka Corporation

Primary outcome measures

  • Effectiveness [Time frame: 6 months]
  • Safety [Time frame: 90 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Westchester Medical Center — Valhalla
  • University of Pennslyvania — Philadelphia

Identifiers

NCT: NCT07214623 · CLIN-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗