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Study to Evaluate Performance, Usability, Safety of Microwave Technology When Collecting Data From Patients With Stroke

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ClinicalTrials.gov Identifier: NCT02266459
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Medfield Diagnostics

Brief Summary:

This is a prospective, open, multicenter study that will enroll patients admitted to and hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers.

The main purpose of the study is to evaluate the ability of the Microwave Technology to deliver adequate measurement data.


Condition or disease Intervention/treatment Phase
Stroke Healthy Device: Microwave technology (Medfield Diagnostics) Not Applicable

Detailed Description:

After written informed consent has been acquired a physical examination will be performed followed by confirmation of the inclusion/exclusion criteria. After subject enrollment the microwave measurement will be performed. The procedure will take approximately 15 minutes (the duration of the actual measurements is < 1 minute) and will not interfere with the patient's standard of care at the Stroke Unit.

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 method with the CT diagnosis as ground truth. Microwave signals are sensitive to the dielectric parameters of the investigated object. In biological matter this is often related to amount of water. Brain tissue has different dielectric properties from blood. The physiological changes inside the brain that occurs as a result of a stroke will change the dielectric parameters.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective, Open, Multicenter Study to Evaluate the Performance, Safety and Usability of the Microwave Technology Developed by Medfield Diagnostics When Collecting Measurement Data From Patients With Clinical Signs of Stroke.
Study Start Date : October 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Intervention Details:
  • Device: Microwave technology (Medfield Diagnostics)
    A microwave measurement will be performed. The procedure will take approximately 15 minutes (the duration of the actual measurements is < 1 minute) and will not interfere with the patient's standard of care at the Stroke Unit.


Primary Outcome Measures :
  1. Ability to deliver adequate measurement data [ Time Frame: The procedure will take approximately 15 minutes ]
    To confirm that the device will deliver adequate measurement data for at least 80 % of the patients diagnosed with Hemorrhagic stroke and Ischemic stroke


Secondary Outcome Measures :
  1. To confirm that the device will deliver adequate measurement data for at least 80 % of the healthy volunteers [ Time Frame: The procedure will take approximately 15 minutes ]
  2. Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C [ Time Frame: The procedure will take approximately 15 minutes ]
  3. To confirm the diagnostic ability of the device using a leave-one-out cross validation method [ Time Frame: The procedure will take approximately 15 minutes ]
  4. Occurrence of adverse events [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

(Group A)

  • Signed Informed Consent Form
  • Patient diagnosed (by CT) with ischemic stroke, within 24 hours of stroke onset
  • Patient should be ≥ 18 years of age

(Group B)

  • Signed Informed Consent Form
  • Patient diagnosed (by CT) with hemorrhagic stroke, within 48 hours of stroke onset
  • Patient should be ≥ 18 years of age

(Group C)

  • Signed Informed Consent Form
  • Subject should be ≥ 18 years of age

Exclusion Criteria:

(Group A+B)

  • Pregnant or nursing woman
  • Woman of child bearing potential and not taking adequate contraceptive precautions
  • Patient that has already received thrombolytic treatment
  • Patient participating in any other clinical study that could interfere with the result in the present study
  • Patient diagnosed with a condition associated with risk of poor protocol compliance
  • 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 enrollment

(Group C)

  • Pregnant or nursing woman
  • Woman of child bearing potential and not taking adequate contraceptive precautions
  • Subject participating in any other clinical study that could interfere with the result in the present study
  • Any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment
  • Any subject 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): NCT02266459


Locations
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Sweden
Strokeenheten, Södra Älvsborgs Sjukhus
Borås, Sweden, 501 82
Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology
Göteborg, Sweden, 41345
Strokeenheten, Skaraborgs Sjukhus
Skövde, Sweden, 541 42
Sponsors and Collaborators
Medfield Diagnostics
Investigators
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Principal Investigator: Jan-Erik Karlsson, MD, PhD Sahlgrenska University hospital/Sahlgrenska, Dept. of Neurology
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Responsible Party: Medfield Diagnostics
ClinicalTrials.gov Identifier: NCT02266459    
Other Study ID Numbers: MF04
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases