StrokeNCT02490306
Evaluating Use of Microwave Technology to Differentiate Hemorrhagic Stroke From Infarction in the Acute Phase
A study testing Strokefinder MD100 measurement in people with Stroke, run by Mikael Elam at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Strokefinder MD100 measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2015to Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital, Stroke Unit
Gothenburg, Västra Götaland County, 413 45
Mikael Elam, PhD, MD, 070-940 10 42, mikael.elam@neuro.gu.se
Mikael Elam, PhD, MD
About this study
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
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.
Read the 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
- Being tested
- Strokefinder MD100 measurement
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strokefinder MD100 measurementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhagic stroke | Experimental | Patient group A is defined as patients that are diagnosed with hemorrhagic stroke.
Interventions: Strokefinder MD100 measurement Receives: Device: Strokefinder MD100 measurement |
| Ischemic stroke | Experimental | Patient group B is defined as patients that are diagnosed with ischemic stroke.
Interventions: Strokefinder MD100 measurement Receives: Device: Strokefinder MD100 measurement |
| Stroke mimics | Experimental | 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 Receives: Device: Strokefinder MD100 measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The diagnostic procedure will take less than 5 minutes
Secondary outcomes (2)
The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B, using the LOOCV method
Measured: The diagnostic procedure will take less than 5 minutes
Any adverse events occurring within 24 hours from the measurement procedure(s)
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mikael Elam
- Sponsor type
- University, hospital or other
- Collaborators
- Medfield Diagnostics, Chalmers University of Technology
- Responsible party
- Sponsor-investigator, Mikael Elam, Sahlgrenska University Hospital
- Investigators
- Mikael Elam, PhD, MD, Principal investigator, Sahlgrenska University Hospital, Department of Clinical Neurophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490306
- Sponsor's protocol ID
- VGR 01
- Status last verified
- Oct 2022
- First submitted
- 29 Jun 2015
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02490306
- Acronym / sponsor ID
- VGR 01
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mikael ElamUniversity, hospital or other
- Collaborators
- Medfield Diagnostics, Chalmers University of Technology
- Study start
- Jul 2015
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Jul 2015 (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, 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemorrhagic stroke | Experimental | Device: Strokefinder MD100 measurementPatient group A is defined as patients that are diagnosed with hemorrhagic stroke. Interventions: Strokefinder MD100 measurement |
| Ischemic stroke | Experimental | Device: Strokefinder MD100 measurementPatient group B is defined as patients that are diagnosed with ischemic stroke. Interventions: Strokefinder MD100 measurement |
| Stroke mimics | Experimental | Device: Strokefinder MD100 measurementPatient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke. Interventions: Strokefinder MD100 measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Strokefinder MD100 measurementA 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. | Device | Hemorrhagic stroke, Ischemic stroke, Stroke mimics |
Primary outcome
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
2 secondary outcomes
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
Any adverse events occurring within 24 hours from the measurement procedure(s)
Time frame: Within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
Related trials for Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy
Acute Ischemic Stroke
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.
Mikael Elam, PhD, MD principal investigator
Sahlgrenska University Hospital, Department of Clinical Neurophysiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strokefinder MD100 measurement in people with Stroke, run by Mikael Elam at 1 site 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikael Elam, PhD, MD (+46(0)70-940 10 42, mikael.elam@neuro.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 28 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.