Clinical trial NCT04257149: Mobile Microwave-based Diagnosis and Monitoring of Stroke
Official title: Mobile Microwave-based Diagnosis and Monitoring of Stroke: on the Road Towards Improved Stroke Triage and Care, Including Prehospital Initiation of Thrombolytic Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Intracerebral Hemorrhage
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
name: Equinor
name: Medfield Diagnostics
name: Nordlandssykehuset HF
First posted: 2020-02-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the diagnostic ability of the device to diagnose hemorrhagic stroke and ischemic stroke in the prehospital and hospital setting
timeFrame: Baseline
Secondary outcomes:
measure: Adverse events within 24 hours
timeFrame: Baseline to 24 hours
measure: To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics
timeFrame: Baseline
measure: To evaluate the delivery of adequate measurement data from the device
timeFrame: Baseline
measure: To evaluate the amount of time needed to perform the measurement procedures
timeFrame: Basline
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Bodø
country: Norway
facility: Norlandsykehuset HF
city: Stavanger
country: Norway
facility: Statoil As
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Martin Kurz, PhD
role: PRINCIPAL_INVESTIGATOR
References: