Clinical trial NCT02490306: Evaluating Use of Microwave Technology to Differentiate Hemorrhagic Stroke From Infarction in the Acute Phase
Official title: An Open Multicentre Trial on Suspected Stroke Patients Evaluating the Possibility to Use Microwave Technology to Differentiate Hemorrhage From Infarction in the Acute Phase
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Medfield Diagnostics
name: Chalmers University of Technology
First posted: 2015-07-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: The diagnostic procedure will take less than 5 minutes
Secondary outcomes:
measure: The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B, using the LOOCV method
timeFrame: The diagnostic procedure will take less than 5 minutes
measure: Any adverse events occurring within 24 hours from the measurement procedure(s)
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Stroke Unit
state: Västra Götaland
Study officials:
affiliation: Sahlgrenska University Hospital, Department of Clinical Neurophysiology
name: Mikael Elam, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: