Stroke, AcuteMODSNCT04257149
Mobile Microwave-based Diagnosis and Monitoring of Stroke
A study testing Hemorrhagic stroke group (group A), Ischemic stroke group (group B) and Stroke mimic group (group C) in people with Stroke, Acute and Intracerebral Hemorrhage, run by Helse Stavanger HF at 4 sites in Norway.
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. 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, Acute, Intracerebral Hemorrhage
- What is being tested?
- Hemorrhagic stroke group (group A), Ischemic stroke group (group B) and Stroke mimic group (group C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesNorway
- Study dates
- 1 Feb 2018to Feb 2025
- 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 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)
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
4 sites in 1 country.
Norway4 sites, 4 recruiting
- Recruiting
Haukeland University Hospital
Bergen
Lars Thomassen, PhD, 55975000, lars.thomassen@helse-bergen.no
- Not yet recruiting
Norlandsykehuset HF
Bodø
Maria Carlsson, 75534000, Maria.Carlsson@nordlandsykehuset.no
- Recruiting
Statoil As
Stavanger, 4017
Atle Houg Ringheim, 95854340, atring@statoil.com
- Recruiting
Stavanger University Hospital
Stavanger, 4017
Martin Kurz, 47246847, martin.kurz@sus.no
About this study
Official title: Mobile Microwave-based Diagnosis and Monitoring of Stroke: on the Road Towards Improved Stroke Triage and Care, Including Prehospital Initiation of Thrombolytic Treatment
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.
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.
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
- Being tested
- Hemorrhagic stroke group (group A), Ischemic stroke group (group B), Stroke mimic group (group C)
- Medical subject headings
- Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemorrhagic stroke group (group A)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)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)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.
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhagic stroke group (group A) | Experimental | Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. Receives: Diagnostic Test: Hemorrhagic stroke group (group A) |
| Ischemic stroke group (group B) | Experimental | Patient group B is defined as patients that are diagnosed with ischemic stroke. Receives: Diagnostic Test: Ischemic stroke group (group B) |
| Stroke mimic group (group C) | Experimental | Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke. Receives: Diagnostic Test: Stroke mimic group (group C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the diagnostic ability of the device to diagnose hemorrhagic stroke and ischemic stroke in the prehospital and hospital setting
The diagnostic ability as measured by the area under the curve of the device for patient groups (group C vs. groups A + B) using the LOOCV method
Measured: Baseline
Secondary outcomes (4)
Adverse events within 24 hours
Any adverse events occurring within 24 hours from the measurement procedure(s)
Measured: Baseline to 24 hours
To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics
To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics from patients with stroke (hemorrhagic stroke and ischemic stroke) in the prehospital and hospital setting
Measured: Baseline
To evaluate the delivery of adequate measurement data from the device
To evaluate the delivery of adequate measurement data from the device in the prehospital and hospital setting
Measured: Baseline
To evaluate the amount of time needed to perform the measurement procedures
To evaluate the amount of time needed to perform the measurement procedures in the prehospital and hospital settings
Measured: Basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Feb 2018
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital, Equinor, Medfield Diagnostics, Nordlandssykehuset HF
- Responsible party
- Sponsor
- Investigators
- Martin Kurz, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257149
- Sponsor's protocol ID
- SUSID663
- Acronym
- MODS
- Status last verified
- Feb 2020
- First submitted
- 1 Feb 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Microwave-based Diagnosis and Monitoring of Stroke: on the Road Towards Improved Stroke Triage and Care, Including Prehospital Initiation of Thrombolytic Treatment
- ClinicalTrials.gov ID
- NCT04257149
- Acronym / sponsor ID
- MODS / SUSID663
- Conditions
- Stroke, Acute, Intracerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Haukeland University Hospital, Equinor, Medfield Diagnostics, Nordlandssykehuset HF
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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. 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemorrhagic stroke group (group A) | Experimental | Diagnostic Test: Hemorrhagic stroke group (group A)Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. |
| Ischemic stroke group (group B) | Experimental | Diagnostic Test: Ischemic stroke group (group B)Patient group B is defined as patients that are diagnosed with ischemic stroke. |
| Stroke mimic group (group C) | Experimental | Diagnostic Test: 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. |
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 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)
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 |
|---|---|---|
| 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. | Diagnostic test | Hemorrhagic stroke group (group A) |
| 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. | Diagnostic test | Ischemic stroke group (group B) |
| 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. | Diagnostic test | Stroke mimic group (group C) |
Primary outcome
To evaluate the diagnostic ability of the device to diagnose hemorrhagic stroke and ischemic stroke in the prehospital and hospital setting
Time frame: Baseline
The diagnostic ability as measured by the area under the curve of the device for patient groups (group C vs. groups A + B) using the LOOCV method
4 secondary outcomes
Adverse events within 24 hours
Time frame: Baseline to 24 hours
To evaluate the diagnostic ability of the device to differentiate patients with stroke mimics
Time frame: Baseline
To evaluate the delivery of adequate measurement data from the device
Time frame: Baseline
To evaluate the amount of time needed to perform the measurement procedures
Time frame: Basline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Martin Kurz, PhD principal investigator
Helse Stavanger HF
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemorrhagic stroke group (group A), Ischemic stroke group (group B) and Stroke mimic group (group C) in people with Stroke, Acute and Intracerebral Hemorrhage, run by Helse Stavanger HF at 4 sites in Norway.
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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. 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 Martin Kurz, PhD (47246847, martin.kurz@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the diagnostic ability of the device to diagnose hemorrhagic stroke and ischemic stroke in the prehospital and hospital setting (time frame: Baseline). 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 5 Feb 2020.