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

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ClinicalTrials.gov Identifier: NCT02490306
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : October 25, 2018
Sponsor:
Collaborators:
Medfield Diagnostics
Chalmers University of Technology
Information provided by (Responsible Party):
Mikael Elam, Sahlgrenska University Hospital, Sweden

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.

Condition or disease Intervention/treatment Phase
Stroke Device: Strokefinder MD100 measurement Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : July 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Hemorrhagic stroke

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

Interventions: Strokefinder MD100 measurement

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.

Experimental: Ischemic stroke

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

Interventions: Strokefinder MD100 measurement

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.

Experimental: 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

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.




Primary Outcome Measures :
  1. 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 [ Time Frame: The diagnostic procedure will take less than 5 minutes ]

Secondary Outcome Measures :
  1. The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B, using the LOOCV method [ Time Frame: The diagnostic procedure will take less than 5 minutes ]
  2. Any adverse events occurring within 24 hours from the measurement procedure(s) [ Time Frame: Within 24 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490306


Contacts
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Contact: Mikael Elam, PhD, MD +46(0)70-940 10 42 mikael.elam@neuro.gu.se
Contact: Stefan J Candefjord, PhD +46(0)73-382 15 37 stefan.candefjord@chalmers.se

Locations
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Sweden
Sahlgrenska University Hospital, Stroke Unit Recruiting
Gothenburg, Västra Götaland, Sweden, 413 45
Contact: Mikael Elam, PhD, MD    070-940 10 42    mikael.elam@neuro.gu.se   
Principal Investigator: Mikael Elam, PhD, MD         
Sub-Investigator: Jan-Erik Karlsson, PhD, MD         
Sponsors and Collaborators
Mikael Elam
Medfield Diagnostics
Chalmers University of Technology
Investigators
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Principal Investigator: Mikael Elam, PhD, MD Sahlgrenska University Hospital, Department of Clinical Neurophysiology

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Responsible Party: Mikael Elam, Professor, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02490306     History of Changes
Other Study ID Numbers: VGR 01
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Stroke
Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis