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

Mobile Microwave-based Diagnosis and Monitoring of Stroke: on the Road Towards Improved Stroke Triage and Care, Including Prehospital Initiation of Thrombolytic Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute; Intracerebral Hemorrhage
• Intervention / Treatment: Diagnostic test: Hemorrhagic stroke group (group A); Diagnostic test: Ischemic stroke group (group B); Diagnostic test: Stroke mimic group (group C)

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Kurz, PhD; Phone Number: 47246847; Email: martin.kurz@sus.no

Study Locations

• Norway
  • Bergen, Norway
    • Recruiting
    • Haukeland University Hospital
    • Contact: Lars Thomassen, PhD; Phone Number: 55975000; Email: lars.thomassen@helse-bergen.no
  • Bodø, Norway
    • Not yet recruiting
    • Norlandsykehuset HF
    • Contact: Maria Carlsson; Phone Number: 75534000; Email: Maria.Carlsson@nordlandsykehuset.no
  • Stavanger, Norway, 4017
    • Recruiting
    • Statoil As
    • Contact: Atle Houg Ringheim; Phone Number: 95854340; Email: atring@statoil.com
  • Stavanger, Norway, 4017
    • Recruiting
    • Stavanger University Hospital
    • Contact: Martin Kurz; Phone Number: 47246847; Email: martin.kurz@sus.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemorrhagic stroke group (group A); Patient group A is defined as patients that are diagnosed with hemorrhagic stroke.	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.
Experimental: Ischemic stroke group (group B); Patient group B is defined as patients that are diagnosed with ischemic stroke.	Diagnostic test: 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.
Experimental: 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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events within 24 hours	Any adverse events occurring within 24 hours from the measurement procedure(s)	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	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	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	Basline

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Collaborators: Haukeland University Hospital; Nordlandssykehuset HF; Medfield Diagnostics; Equinor
• Investigators: Principal Investigator: Martin Kurz, PhD, Helse Stavanger HF

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Stroke; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: SUSID663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No