Health TrialsbyHealthPanel

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

ConditionsChronic Subdural HematomacSDHChronic Subdural Hematomas
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

This trial does not accept healthy volunteers

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 population

Patients with chronic subdural hematomas with symptoms

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Neuro endovascular embolic coil

    Device

    i-ED COIL, Kaneka Corporation

Treatment groups

No treatment groups listed

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaneka Medical America LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: