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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKaneka Medical America LLC

About this trial

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.

Eligibility criteria

Qualifiers

Pre morbid mRS 0-3

Chronic subdural symptomatic, requiring intervention

Disqualifiers

Acute subdural hematoma

Intercranial mass other than subdural hematoma

Females pregnant or breast feeding

Compromised survival or inability to complete trial

Trial design

Treatments tested in this trial

  • Neuro endovascular embolic coil

Treatment groups

No treatment groups listed

Sponsors and collaborators