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

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ClinicalTrials.gov Identifier: NCT04622644
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : August 23, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Stroke Hemorrhagic Device: Device: clinical investigation microwave device class IIa not marked CE for stroke detection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study Using a Microwave Device for Stroke Detection (StrokeWave) to Discriminate Between Haemorragic and Ischaemic Stroke
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arm Intervention/treatment
Experimental: Single Arm
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.




Primary Outcome Measures :
  1. To generate empirical evidence that StrokeWave can detect and distinguish beteween haemorragic and ischaemic stroke at the same extent as NCCT [ Time Frame: 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 :
  1. StrokeWave sensitivity in the ischaemic stroke [ Time Frame: During the baseline ]
    To measure the sensitivity of StrokeWave in the ischaemic stroke (ASPECT scale)

  2. StrokeWave sensitivity in the haemorragic stroke [ Time Frame: During the baseline ]
    To measure the sensitivity of StrokeWave in the haemorragic stroke (site, dimension)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622644


Contacts
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Contact: Gianluigi Tiberi +39 3490564302 gianluigi@ubt-tech.com

Locations
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Italy
Ospedale Nuovo Santa Chiara Recruiting
Pisa, Italy, 56126
Contact: Mirco Cosottini    +39 050 996635    mirco.cosottini@unipi.it   
Sponsors and Collaborators
Umbria Bioengineering Technologies
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Responsible Party: Umbria Bioengineering Technologies
ClinicalTrials.gov Identifier: NCT04622644    
Other Study ID Numbers: UBT-01-20
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: August 23, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Hemorrhagic Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes