StrokeNCT02266459
Study to Evaluate Performance, Usability, Safety of Microwave Technology When Collecting Data From Patients With Stroke
A study testing Microwave technology (Medfield Diagnostics) in people with Stroke and Healthy, run by Medfield Diagnostics at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Microwave technology (Medfield Diagnostics)
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 3 sitesSweden
- Study dates
- Oct 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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
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- 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
Who cannot join
- (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
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- 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
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Strokeenheten, Södra Älvsborgs Sjukhus
Borås, Borås, 501 82
Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology
Gothenburg, Göteborg, 41345
Strokeenheten, Skaraborgs Sjukhus
Skövde, 541 42
About this study
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.
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.
Read the 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.
- Being tested
- Microwave technology (Medfield Diagnostics)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave technology (Medfield Diagnostics)Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to deliver adequate measurement data
To confirm that the device will deliver adequate measurement data for at least 80 % of the patients diagnosed with Hemorrhagic stroke and Ischemic stroke
Measured: The procedure will take approximately 15 minutes
Secondary outcomes (4)
To confirm that the device will deliver adequate measurement data for at least 80 % of the healthy volunteers
Measured: The procedure will take approximately 15 minutes
Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C
Measured: The procedure will take approximately 15 minutes
To confirm the diagnostic ability of the device using a leave-one-out cross validation method
Measured: The procedure will take approximately 15 minutes
Occurrence of adverse events
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medfield Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan-Erik Karlsson, MD, PhD, Principal investigator, Sahlgrenska University hospital/Sahlgrenska, Dept. of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266459
- Sponsor's protocol ID
- MF04
- Status last verified
- Aug 2015
- First submitted
- 13 Oct 2014
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02266459
- Acronym / sponsor ID
- MF04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Medfield DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- (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)
Key exclusion criteria (14 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
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
4 secondary outcomes
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
Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C
Time frame: The procedure will take approximately 15 minutes
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
Occurrence of adverse events
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan-Erik Karlsson, MD, PhD principal investigator
Sahlgrenska University hospital/Sahlgrenska, Dept. of Neurology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave technology (Medfield Diagnostics) in people with Stroke and Healthy, run by Medfield Diagnostics at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to deliver adequate measurement data (time frame: The procedure will take approximately 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.