Mobile Microwave-based Diagnosis and Monitoring of Stroke

Helse Stavanger HF500 enrolled

Overview

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. The study assesses the diagnostic capability and safety of Strokefinder MD100.

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. The investigator will assess and control the inclusion/exclusion criteria. If the patient is confirmed to be suitable for the trial, the patient is asked to give oral informed consent. If the answer is affirmative the microwave measurement will be performed. The procedure will take less than five minutes (the duration of the actual measurement procedure is 1.5 minutes) and will not interfere with the patient's standard of care during the hospital stay. Written informed consent is acquired by the investigator, as soon as possible after the acute phase of care is completed. The measurement data will be evaluated for the presence of signal artifacts. The diagnostic ability of the device will be evaluated using a leave-one-out cross validation (LOOCV) method with the CT diagnosis as ground truth. Safety will be evaluated throughout the trial, and a safety follow-up will be performed by the investigator 24 hours after the last microwave measurement. No further follow-up of patients is planned.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

500

Conditions

Stroke, Acute Intracerebral Hemorrhage

Interventions

Hemorrhagic stroke group (group A)DIAGNOSTIC_TEST

Group A: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.

Ischemic stroke group (group B)DIAGNOSTIC_TEST

Group B: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.

Stroke mimic group (group C)DIAGNOSTIC_TEST

Group C: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with clinical signs of stroke * Patient should be ≥ 18 years of age * Patient/next of kin confirms orally that the patient wants to participate in the trial (during acute phase) * Signed Informed Consent Form (after acute phase) Exclusion Criteria: * Pregnant or nursing woman * Fertile woman where pregnancy cannot be excluded * Patient diagnosed with a condition associated with risk of poor protocol compliance * The diagnostic procedure is deemed to interfere with the standard of care * Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment * Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrolment

Locations (4)

Haukeland University Hospital

Bergen, Norway

RECRUITING

Norlandsykehuset HF

Bodø, Norway

NOT_YET_RECRUITING

Statoil As

Stavanger, Norway

RECRUITING

Outcomes

Primary Outcomes

To evaluate the diagnostic ability of the device to diagnose hemorrhagic stroke and ischemic stroke in the prehospital and hospital setting

The diagnostic ability as measured by the area under the curve of the device for patient groups (group C vs. groups A + B) using the LOOCV method

Time frame: Baseline

Secondary Outcomes

Adverse events within 24 hours

Any adverse events occurring within 24 hours from the measurement procedure(s)

Time frame: Baseline to 24 hours

To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics

To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics from patients with stroke (hemorrhagic stroke and ischemic stroke) in the prehospital and hospital setting

Time frame: Baseline

To evaluate the delivery of adequate measurement data from the device

To evaluate the delivery of adequate measurement data from the device in the prehospital and hospital setting

Time frame: Baseline

To evaluate the amount of time needed to perform the measurement procedures

To evaluate the amount of time needed to perform the measurement procedures in the prehospital and hospital settings

Time frame: Basline

Central Contacts

Martin Kurz, PhD

CONTACT

47246847 martin.kurz@sus.no

Data from ClinicalTrials.gov

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