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

Not Applicable

Completed

• Conditions: Stroke Hemorrhagic; Stroke, Ischemic

• Registration Number: NCT04622644
• Lead Sponsor: Umbria Bioengineering Technologies

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-10
• Study Start: 2021-02-23
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult > 18 years old
• Patients with hyperacute stroke, i.e. which are referred to the emergency room with a 'stroke code'

Exclusion Criteria

• mRS >3 before the stroke onset
• Life expectancy <3 months
• GCS=3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To generate empirical evidence that StrokeWave can detect and distinguish beteween haemorragic and ischaemic stroke at the same extent as NCCT	During the baseline	StrokeWave ability to distinguish between haemorragic and ischaemic stroke compared to NCCT results (concordance between ischaemic and haemorragic strokes identified with 2 methods)

Secondary Outcome Measures

Name	Time	Method
StrokeWave sensitivity in the ischaemic stroke	During the baseline	To measure the sensitivity of StrokeWave in the ischaemic stroke (ASPECT scale)
StrokeWave sensitivity in the haemorragic stroke	During the baseline	To measure the sensitivity of StrokeWave in the haemorragic stroke (site, dimension)

Trial Locations

Locations (1)

Ospedale Nuovo Santa Chiara; 🇮🇹 Pisa, Italy