An interventional study of Device: clinical investigation microwave device class IIa not marked CE for stroke detection in Stroke, Ischemic and Stroke Hemorrhagic, sponsored by Umbria Bioengineering Technologies. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Umbria Bioengineering Technologies · Not applicable, Interventional, and Diagnostic
This is a pilot, monocentric clinical investigation to evaluate the suitability of StrokeWave in distinguishing haemorragic from ischaemic strokes. The StrokeWave is a microwave device which employs a novel technique to generate images by processing very low power (\<1mW) microwaves. The trial design has been developed in order not to interfere with thw standard diagnostic approach used for the hyperacute stroke patients, nor to modify the usual standard timing of the routine assessment.
The number of participants will be 60. Patients with hyperacute stroke (within 4 hours from the onset) or with awake or unknow time of onset strokes will be enrolled in the study. All patients will be registered at emergency room of Hospital, and according to the internal procedure will be clinically evaluated by the Neurologist of the stroke team. NIHSS and mRS will be administered and scores registered. The scanning with StrokeWave will be performed in 5 minutes, after NCCT and before the CTA acquisition, in the CT room. 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. After the StrokeWave scanning, the system will be removed. The data collected will be processed through an imaging algorithm which is integrated in the device. The final output will be composed by one or more images, plus one or more parameters describing the images.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Umbria Bioengineering Technologies is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients perform StrokeWave exam, after NCCT and before CTA acquisition.
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.
To generate empirical evidence that StrokeWave can detect and distinguish beteween haemorragic and ischaemic stroke at the same extent as NCCT
StrokeWave ability to distinguish between haemorragic and ischaemic stroke compared to NCCT results (concordance between ischaemic and haemorragic strokes identified with 2 methods)
Time frame: During the baseline
StrokeWave sensitivity in the ischaemic stroke
To measure the sensitivity of StrokeWave in the ischaemic stroke (ASPECT scale)
Time frame: During the baseline
StrokeWave sensitivity in the haemorragic stroke
To measure the sensitivity of StrokeWave in the haemorragic stroke (site, dimension)
Time frame: During the baseline
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Umbria Bioengineering Technologies