Mobile Microwave-based Diagnosis and Monitoring of Stroke (MODS)

Helse Stavanger HF

Status: Enrolling

Conditions: Stroke, Acute; Intracerebral Hemorrhage

Treatments: Diagnostic Test: Ischemic stroke group (group B); Diagnostic Test: Stroke mimic group (group C); Diagnostic Test: Hemorrhagic stroke group (group A)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04257149

SUSID663

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 3 patient groups

Hemorrhagic stroke group (group A)

Experimental group

Description:

Patient group A is defined as patients that are diagnosed with hemorrhagic stroke.

Treatment:

Diagnostic Test: Hemorrhagic stroke group (group A)

Ischemic stroke group (group B)

Experimental group

Description:

Patient group B is defined as patients that are diagnosed with ischemic stroke.

Treatment:

Diagnostic Test: Ischemic stroke group (group B)

Stroke mimic group (group C)

Experimental group

Description:

Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke.

Treatment:

Diagnostic Test: Stroke mimic group (group C)