Mobile Microwave-based Diagnosis and Monitoring of Stroke
MODS
1 other identifier
interventional
500
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedFebruary 5, 2020
February 1, 2020
4 years
February 1, 2018
February 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Adverse events within 24 hours
Baseline to 24 hours
To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics
Baseline
To evaluate the delivery of adequate measurement data from the device
Baseline
To evaluate the amount of time needed to perform the measurement procedures
Basline
Study Arms (3)
Hemorrhagic stroke group (group A)
EXPERIMENTALPatient group A is defined as patients that are diagnosed with hemorrhagic stroke.
Ischemic stroke group (group B)
EXPERIMENTALPatient group B is defined as patients that are diagnosed with ischemic stroke.
Stroke mimic group (group C)
EXPERIMENTALPatient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse Stavanger HFlead
- Haukeland University Hospitalcollaborator
- Equinorcollaborator
- Medfield Diagnosticscollaborator
- Nordlandssykehuset HFcollaborator
Study Sites (4)
Haukeland University Hospital
Bergen, Norway
Norlandsykehuset HF
Bodø, Norway
Statoil As
Stavanger, 4017, Norway
Stavanger University Hospital
Stavanger, 4017, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Kurz, PhD
Helse Stavanger HF
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2018
First Posted
February 5, 2020
Study Start
February 1, 2018
Primary Completion
February 1, 2022
Study Completion
February 1, 2025
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share