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

NCT04622644 | Completed

• 1 other identifier: UBT-01-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• StrokeWave sensitivity in the ischaemic stroke

  During the baseline

• StrokeWave sensitivity in the haemorragic stroke

  During the baseline

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

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

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Umbria Bioengineering Technologies: lead

Study Sites (1)

Ospedale Nuovo Santa Chiara

Pisa, 56126, Italy

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 10, 2020
• Study Start: February 23, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

IT (1)