Clinical Investigation to Evaluate the Suitability of StrokeWave in Distinguishing Haemorragic From Ischaemic Strokes

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 23, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Stroke, IschemicStroke Hemorrhagic
Interventions
DEVICE

Device: clinical investigation microwave device class IIa not marked CE for stroke detection

Patients with hyperacute stroke are referred to the emergency room with a 'stroke code'. Clinical collected data includes NIHSS and mRS. Patients will undergo to NCCT in order to exclude the haemorragic nature of vascular disease. In the same diagnostic session the patient undergo to CTA with tri-phase protocol to assess LVO. Before starting the CTA acquisition with iodinate contrast injection the StrokeWave will be placed on the head of the patients in the CT room passing toward the gantry of the CT avoiding any loose of time. The scanning with the StrokeWave will be performed in about 5 minutes and the system will be removed allowing the CTA acquisition.

Trial Locations (1)

56126

Ospedale Nuovo Santa Chiara, Pisa

All Listed Sponsors
lead

Umbria Bioengineering Technologies

INDUSTRY

NCT04622644 - Clinical Investigation to Evaluate the Suitability of StrokeWave in Distinguishing Haemorragic From Ischaemic Strokes | Biotech Hunter | Biotech Hunter