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

Stroke, Ischemic Clinical Trial

Official title:

A Pilot Study Using a Microwave Device for Stroke Detection (StrokeWave) to Discriminate Between Haemorragic and Ischaemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622644
• Other study ID #: UBT-01-20
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Umbria Bioengineering Technologies
• Contact: Gianluigi Tiberi
• Phone: +39 3490564302
• Email: gianluigi[@]ubt-tech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale Nuovo Santa Chiara	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Umbria Bioengineering Technologies

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	During the baseline
Secondary	StrokeWave sensitivity in the ischaemic stroke	To measure the sensitivity of StrokeWave in the ischaemic stroke (ASPECT scale)	During the baseline
Secondary	StrokeWave sensitivity in the haemorragic stroke	To measure the sensitivity of StrokeWave in the haemorragic stroke (site, dimension)	During the baseline