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

NCT ID: NCT02490306

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2023-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Hemorrhagic stroke

Patient group A is defined as patients that are diagnosed with hemorrhagic stroke.

Interventions: Strokefinder MD100 measurement

Group Type: EXPERIMENTAL

Strokefinder MD100 measurement

Intervention Type: DEVICE

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.

Ischemic stroke

Patient group B is defined as patients that are diagnosed with ischemic stroke.

Interventions: Strokefinder MD100 measurement

Group Type: EXPERIMENTAL

Strokefinder MD100 measurement

Intervention Type: DEVICE

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.

Stroke mimics

Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke.

Interventions: Strokefinder MD100 measurement

Group Type: EXPERIMENTAL

Strokefinder MD100 measurement

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medfield Diagnostics

INDUSTRY

Sponsor Role: collaborator

Chalmers University of Technology

OTHER

Sponsor Role: collaborator

Mikael Elam

OTHER

Sponsor Role: lead

Responsible Party

Mikael Elam

Professor, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mikael Elam, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital, Department of Clinical Neurophysiology

Locations

Sahlgrenska University Hospital, Stroke Unit

Gothenburg, Västra Götaland County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Mikael Elam, PhD, MD

Role: CONTACT

mikael.elam@neuro.gu.se

+46(0)70-940 10 42

Stefan J Candefjord, PhD

Role: CONTACT

stefan.candefjord@chalmers.se

+46(0)73-382 15 37

Facility Contacts

Mikael Elam, PhD, MD

Role: primary

mikael.elam@neuro.gu.se

070-940 10 42

Other Identifiers

VGR 01

Identifier Type: -

Identifier Source: org_study_id