Mobile Microwave-based Diagnosis and Monitoring of Stroke

NCT ID: NCT04257149

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2025-02-28

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.

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.

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, Acute; Intracerebral Hemorrhage

Study Design

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

Study Groups

Hemorrhagic stroke group (group A)

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

Group Type: EXPERIMENTAL

Hemorrhagic stroke group (group A)

Intervention Type: DIAGNOSTIC_TEST

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.

Ischemic stroke group (group B)

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

Group Type: EXPERIMENTAL

Ischemic stroke group (group B)

Intervention Type: DIAGNOSTIC_TEST

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.

Stroke mimic group (group C)

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

Group Type: EXPERIMENTAL

Stroke mimic group (group C)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Hemorrhagic stroke group (group A)

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.

Intervention Type: DIAGNOSTIC_TEST

Ischemic stroke group (group B)

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.

Intervention Type: DIAGNOSTIC_TEST

Stroke mimic group (group C)

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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)

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

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Equinor

UNKNOWN

Sponsor Role: collaborator

Medfield Diagnostics

INDUSTRY

Sponsor Role: collaborator

Nordlandssykehuset HF

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Kurz, PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Norlandsykehuset HF

Bodø, , Norway

Site Status: NOT_YET_RECRUITING

Statoil As

Stavanger, , Norway

Site Status: RECRUITING

Stavanger University Hospital

Stavanger, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Martin Kurz, PhD

Role: CONTACT

martin.kurz@sus.no

47246847

Facility Contacts

Lars Thomassen, PhD

Role: primary

lars.thomassen@helse-bergen.no

55975000

Maria Carlsson

Role: primary

Maria.Carlsson@nordlandsykehuset.no

75534000

Atle Houg Ringheim

Role: primary

atring@statoil.com

95854340

Martin Kurz

Role: primary

martin.kurz@sus.no

47246847

Other Identifiers

SUSID663

Identifier Type: -

Identifier Source: org_study_id