Mobile Microwave-based Diagnosis and Monitoring of Stroke

Not Applicable

Recruiting

• Conditions: Stroke, Acute; Intracerebral Hemorrhage
• Interventions: Diagnostic Test: Hemorrhagic stroke group (group A); Diagnostic Test: Stroke mimic group (group C); Diagnostic Test: Ischemic stroke group (group B)

• Registration Number: NCT04257149
• Lead Sponsor: Helse Stavanger HF

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-02-01
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-04
• Last Update Submitted: 2020-02-04
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2022-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemorrhagic stroke group (group A)	Hemorrhagic stroke group (group A)	Patient group A is defined as patients that are diagnosed with hemorrhagic stroke.
Stroke mimic group (group C)	Stroke mimic group (group C)	Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke.
Ischemic stroke group (group B)	Ischemic stroke group (group B)	Patient group B is defined as patients that are diagnosed with ischemic stroke.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To evaluate the amount of time needed to perform the measurement procedures	Basline	To evaluate the amount of time needed to perform the measurement procedures in the prehospital and hospital settings
Adverse events within 24 hours	Baseline to 24 hours	Any adverse events occurring within 24 hours from the measurement procedure(s)
To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics	Baseline	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
To evaluate the delivery of adequate measurement data from the device	Baseline	To evaluate the delivery of adequate measurement data from the device in the prehospital and hospital setting

Trial Locations

Locations (4)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Norlandsykehuset HF; 🇳🇴 Bodø, Norway

Statoil As; 🇳🇴 Stavanger, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway