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

NCT ID: NCT04622644

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2024-12-31

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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single Arm

All patients perform StrokeWave exam, after NCCT and before CTA acquisition.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umbria Bioengineering Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ospedale Nuovo Santa Chiara

Pisa, , Italy

Countries

Italy

Other Identifiers

UBT-01-20

Identifier Type: -

Identifier Source: org_study_id