Evaluating Use of Microwave Technology to Differentiate Hemorrhagic Stroke From Infarction in the Acute Phase

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02490306
• Other study ID #: VGR 01
• Status: Recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Mikael Elam, PhD, MD
• Phone: +46(0)70-940 10 42
• Email: mikael.elam[@]neuro.gu.se
• 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. Follow-up microwave measurements will be performed after the acute phase. 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Stroke

Intervention

Device:
• Strokefinder 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.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital, Stroke Unit	Gothenburg	Västra Götaland

Sponsors (3)

Lead Sponsor	Collaborator
Mikael Elam	Chalmers University of Technology, Medfield Diagnostics

Country where clinical trial is conducted

Sweden, 

Outcome

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