Stroke, IschemicNCT04622644
Clinical Investigation to Evaluate the Suitability of StrokeWave in Distinguishing Haemorragic From Ischaemic Strokes
A study testing Device: clinical investigation microwave device class IIa not marked CE for stroke detection in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Umbria Bioengineering Technologies at 1 site in Italy.
Trial summary
This is a pilot, monocentric clinical investigation to evaluate the suitability of StrokeWave in distinguishing haemorragic from ischaemic strokes. The StrokeWave is a microwave device which employs a novel technique to generate images by processing very low power (<1mW) microwaves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic
- What is being tested?
- Device: clinical investigation microwave device class IIa not marked CE for stroke detection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 23 Feb 2021to 31 Dec 2024
- 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
- Adult > 18 years old
- Patients with hyperacute stroke, i.e. which are referred to the emergency room with a 'stroke code'
Who cannot join
- mRS >3 before the stroke onset
- Life expectancy <3 months
- GCS=3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Using a Microwave Device for Stroke Detection (StrokeWave) to Discriminate Between Haemorragic and Ischaemic Stroke
This is a pilot, monocentric clinical investigation to evaluate the suitability of StrokeWave in distinguishing haemorragic from ischaemic strokes. The StrokeWave is a microwave device which employs a novel technique to generate images by processing very low power (<1mW) microwaves. The trial design has been developed in order not to interfere with thw standard diagnostic approach used for the hyperacute stroke patients, nor to modify the usual standard timing of the routine assessment.
Read the detailed description
The number of participants will be 60. Patients with hyperacute stroke (within 4 hours from the onset) or with awake or unknow time of onset strokes will be enrolled in the study. All patients will be registered at emergency room of Hospital, and according to the internal procedure will be clinically evaluated by the Neurologist of the stroke team. NIHSS and mRS will be administered and scores registered. The scanning with StrokeWave will be performed in 5 minutes, after NCCT and before the CTA acquisition, in the CT room. StrokeWave will be placed on the head of the patients in the CT room passing toward the gantry of the CT avoiding any loose of time. After the StrokeWave scanning, the system will be removed. The data collected will be processed through an imaging algorithm which is integrated in the device. The final output will be composed by one or more images, plus one or more parameters describing the images.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic
- Being tested
- Device: clinical investigation microwave device class IIa not marked CE for stroke detection
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: clinical investigation microwave device class IIa not marked CE for stroke detectionDevice
Patients with hyperacute stroke are referred to the emergency room with a 'stroke code'. Clinical collected data includes NIHSS and mRS. Patients will undergo to NCCT in order to exclude the haemorragic nature of vascular disease. In the same diagnostic session the patient undergo to CTA with tri-phase protocol to assess LVO. Before starting the CTA acquisition with iodinate contrast injection the StrokeWave will be placed on the head of the patients in the CT room passing toward the gantry of the CT avoiding any loose of time. The scanning with the StrokeWave will be performed in about 5 minutes and the system will be removed allowing the CTA acquisition.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All patients perform StrokeWave exam, after NCCT and before CTA acquisition. Receives: Device: Device: clinical investigation microwave device class IIa not marked CE for stroke detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To generate empirical evidence that StrokeWave can detect and distinguish beteween haemorragic and ischaemic stroke at the same extent as NCCT
StrokeWave ability to distinguish between haemorragic and ischaemic stroke compared to NCCT results (concordance between ischaemic and haemorragic strokes identified with 2 methods)
Measured: During the baseline
Secondary outcomes (2)
StrokeWave sensitivity in the ischaemic stroke
To measure the sensitivity of StrokeWave in the ischaemic stroke (ASPECT scale)
Measured: During the baseline
StrokeWave sensitivity in the haemorragic stroke
To measure the sensitivity of StrokeWave in the haemorragic stroke (site, dimension)
Measured: During the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start23 Feb 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umbria Bioengineering Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622644
- Sponsor's protocol ID
- UBT-01-20
- Status last verified
- Jan 2025
- First submitted
- 2 Nov 2020
- Last updated
- 6 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using a Microwave Device for Stroke Detection (StrokeWave) to Discriminate Between Haemorragic and Ischaemic Stroke
- ClinicalTrials.gov ID
- NCT04622644
- Acronym / sponsor ID
- UBT-01-20
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Umbria Bioengineering TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Nov 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 pilot, monocentric clinical investigation to evaluate the suitability of StrokeWave in distinguishing haemorragic from ischaemic strokes. The StrokeWave is a microwave device which employs a novel technique to generate images by processing very low power (<1mW) microwaves. The trial design has been developed in order not to interfere with thw standard diagnostic approach used for the hyperacute stroke patients, nor to modify the usual standard timing of the routine assessment.
Detailed description
The number of participants will be 60. Patients with hyperacute stroke (within 4 hours from the onset) or with awake or unknow time of onset strokes will be enrolled in the study. All patients will be registered at emergency room of Hospital, and according to the internal procedure will be clinically evaluated by the Neurologist of the stroke team. NIHSS and mRS will be administered and scores registered. The scanning with StrokeWave will be performed in 5 minutes, after NCCT and before the CTA acquisition, in the CT room. StrokeWave will be placed on the head of the patients in the CT room passing toward the gantry of the CT avoiding any loose of time. After the StrokeWave scanning, the system will be removed. The data collected will be processed through an imaging algorithm which is integrated in the device. The final output will be composed by one or more images, plus one or more parameters describing the images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Device: clinical investigation microwave device class IIa not marked CE for stroke detectionAll patients perform StrokeWave exam, after NCCT and before CTA acquisition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult > 18 years old
- Patients with hyperacute stroke, i.e. which are referred to the emergency room with a 'stroke code'
Key exclusion criteria (3 listed)
- mRS >3 before the stroke onset
- Life expectancy <3 months
- GCS=3
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 |
|---|---|---|
| Device: clinical investigation microwave device class IIa not marked CE for stroke detectionPatients with hyperacute stroke are referred to the emergency room with a 'stroke code'. Clinical collected data includes NIHSS and mRS. Patients will undergo to NCCT in order to exclude the haemorragic nature of vascular disease. In the same diagnostic session the patient undergo to CTA with tri-phase protocol to assess LVO. Before starting the CTA acquisition with iodinate contrast injection the StrokeWave will be placed on the head of the patients in the CT room passing toward the gantry of the CT avoiding any loose of time. The scanning with the StrokeWave will be performed in about 5 minutes and the system will be removed allowing the CTA acquisition. | Device | Single Arm |
Primary outcome
To generate empirical evidence that StrokeWave can detect and distinguish beteween haemorragic and ischaemic stroke at the same extent as NCCT
Time frame: During the baseline
StrokeWave ability to distinguish between haemorragic and ischaemic stroke compared to NCCT results (concordance between ischaemic and haemorragic strokes identified with 2 methods)
2 secondary outcomes
StrokeWave sensitivity in the ischaemic stroke
Time frame: During the baseline
StrokeWave sensitivity in the haemorragic stroke
Time frame: During the baseline
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 6 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: clinical investigation microwave device class IIa not marked CE for stroke detection in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Umbria Bioengineering Technologies at 1 site in Italy.
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 2 inclusion and 3 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 6 Jan 2025. 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 Italy. 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?
To generate empirical evidence that StrokeWave can detect and distinguish beteween haemorragic and ischaemic stroke at the same extent as NCCT (time frame: During the 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 6 Jan 2025.