Stroke
Conditions
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. Follow-up microwave measurements will be performed after the acute phase. 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. Follow-up microwave measurements will be performed after the acute phase. 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.
Interventions
DEVICEStrokefinder MD100 measurement
A microwave measurement will be performed with the patient lying in the hospital bed or another suitable surface. Follow-up microwave measurements will be performed after the acute phase.
Sponsors
Medfield Diagnostics
Chalmers University of Technology
Mikael Elam
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient should be ≥ 18 years of age * Patient has clinical signs of stroke * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for patient group A vs. group B, using the leave-one-out cross validation (LOOCV) method | The diagnostic procedure will take less than 5 minutes |
Secondary
| Measure | Time frame |
|---|---|
| The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B, using the LOOCV method | The diagnostic procedure will take less than 5 minutes |
| Any adverse events occurring within 24 hours from the measurement procedure(s) | Within 24 hours |
Countries
Sweden
Contacts
Primary ContactMikael Elam, PhD, MD
Backup ContactStefan J Candefjord, PhD
Outcome results
None listed