Mobile Microwave-based Diagnosis and Monitoring of Stroke

Stroke, Acute Clinical Trial

— MODS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04257149
• Other study ID #: SUSID663
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: February 2025

Study information

• Verified date: February 2020
• Source: Helse Stavanger HF
• Contact: Martin Kurz, PhD
• Phone: 47246847
• Email: martin.kurz[@]sus.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2025
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Stroke
• Stroke, Acute

Intervention

Diagnostic Test:
• Hemorrhagic stroke group (group A)
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)
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)
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.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Norlandsykehuset HF	Bodø
Norway	Statoil As	Stavanger
Norway	Stavanger University Hospital	Stavanger

Sponsors (5)

Lead Sponsor	Collaborator
Helse Stavanger HF	Equinor, Haukeland University Hospital, Medfield Diagnostics, Nordlandssykehuset HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Secondary	Adverse events within 24 hours	Any adverse events occurring within 24 hours from the measurement procedure(s)	Baseline to 24 hours
Secondary	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	Baseline
Secondary	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	Baseline
Secondary	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	Basline