Stroke, AcuteNCT03897153
Evaluation of the SONAS® Ultrasound Device for the Assessment of Bilateral Cerebral Perfusion in Subjects With Acute Stroke
A study testing SONAS® Ultrasound Device in people with Stroke, Acute, run by Burl Concepts, Inc. at 2 sites in 2 countries.
Trial summary
The purpose of this clinical investigation is to determine the safety and feasibility of detecting acoustic signals related to blood supply in subjects with acute large vessel occlusion (LVO) stroke by using the SONAS® device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- SONAS® Ultrasound Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Feb 2019to Oct 2019
- 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
- Written informed consent obtained
- Male or female subject ≥18 years
- Clinical diagnosis of acute stroke (NIHSS score: ≥10)
- Time of stroke symptoms onset: ≤24 hours
- Confirmed occlusion of either the proximal middle cerebral artery (occlusion of the proximal, middle or distal M1-segment) or the distal internal carotid artery (including carotid-T occlusion) by cMRI or cCT (including perfusion weighted imaging sequences)
- Women of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin result, obtained within 24 hours before administration of SonoVue®
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- Women of non-childbearing potential can be included in the clinical investigation, if confirmed by fulfilling at least 1 of the following criteria:
- Postmenopausal (age-related amenorrhea for ≥12 consecutive months)
- Documentation (based on medical records, medical examination, or medical history interview) of irreversible surgical sterilization by bilateral oophorectomy, bilateral salpingectomy, or hysterectomy
Who cannot join
- Subjects with known contraindications to the use of SonoVue®:
- Subjects known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and subjects with acute respiratory distress syndrome
- SonoVue® must not be used in combination with dobutamine in subjects with conditions suggesting cardiovascular instability where dobutamine is contraindicated
- Known hypersensitivity to any of the following substances:
- Sulphur hexafluoride
- Macrogol 4000
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- Distearoylphosphatidylcholine
- Dipalmitoylphosphatidylglycerol sodium
- Palmitic acid
- Pregnant women
- Subjects with severe cardiac or pulmonary disease as defined by the treating physician
- Subjects with acute endocarditis and/or artificial heart valve
- Subjects with acute systemic inflammation and/or sepsis
- Subjects with hyperactive coagulation states and/or a recent thromboembolism
- Subjects with end stage renal or hepatic disease
- Subjects with known metal skull implants in the anatomical area of the temporal/parietal bones, or with anatomical formation of the head or ear that may interfere with proper headset placement, or with significant observable asymmetry in head formation
- Subjects with known implanted deep brain stimulation devices
- Subjects with known or suspected fracture(s) of the temporal/parietal skull bones, or with open skin injuries in the anatomical area of the temporal/parietal lobes
- Subjects with known significant blood loss prior to or during the test procedure, SONAS® should not be used unless the blood pressure of the subject is verified to be stabilized
- Subjects with axial (coronal) skull diameters of <12 cm or >18 cm
- Subjects participating in another clinical investigation with an investigational drug or device within 3 months of enrollment or planned participation at any time during this clinical investigation
- Previous participation in this clinical investigation
- Employees of the clinical investigation site or the sponsor directly involved with the conduct of the clinical investigation, or immediate family members of any such individuals
- Subjects committed to an institution by an order issued either by the courts or by an authority
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Not yet recruiting
Universitätsklinik für Neurologie / Medizinische Universität Wien
Vienna, 1090
Sonja Wieszmüllner, +43(1) 404 00-31210
Assoc. Prof. Priv. Doz. Dr. Stefan Greisenegger
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinik für Neurologie / Universitätsklinikum Regensburg
Regensburg, 93053
Claudia Koeppl, +49 941 941 3502, claudia.koeppl@medbo.de
Prof. Christian Stroszczynski, MD
About this study
The purpose of this clinical investigation is to determine the safety and feasibility of detecting acoustic signals related to blood supply in subjects with acute large vessel occlusion (LVO) stroke by using the SONAS® device.
Read the detailed description
This clinical investigation will assess the performance of the SONAS® device in subjects with acute stroke admitted to the emergency department or stroke unit within 24 hours of symptoms onset and confirmed occlusion of either the proximal middle, distal M1-segment cerebral arteries, or distal internal carotid arteries (including carotid-T occlusion) by cerebral magnetic resonance imaging (cMRI) or cerebral imaging computed tomography (cCT), including perfusion weighted (pw) imaging sequences, will be considered for the investigation.
- Conditions
- Stroke, Acute
- Being tested
- SONAS® Ultrasound Device
- Keywords
- Stroke, Acute
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SONAS® Ultrasound DeviceDevice
The SONAS® Ultrasound Device is intended for non-invasive transcranial ultrasound and used with a commercially approved contrast agent (e.g., Lumason®/SonoVue®).
| Study group | Role | What they receive |
|---|---|---|
| Experimental:Diagnostic | Experimental | Diagnostic Test: SONAS® Ultrasound Device Receives: Device: SONAS® Ultrasound Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Brain Perfusion
Measurement of the kinetic parameter time to peak (TTP) in the right and left-brain hemisphere during the SONAS® test
Measured: 24 hours
Comparison
Comparison between SONAS® versus cMRI or cCT generated intra-individual differences in the parameter TTP in the right and left-brain hemisphere
Measured: 7 days
Assessment of Adverse Events
Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start12 Feb 2019
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burl Concepts, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897153
- Sponsor's protocol ID
- SONAS2018
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2019
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the SONAS® Ultrasound Device for the Assessment of Bilateral Cerebral Perfusion in Subjects With Acute Stroke
- ClinicalTrials.gov ID
- NCT03897153
- Acronym / sponsor ID
- SONAS2018
- Conditions
- Stroke, Acute
- Keywords
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Burl Concepts, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 1 Apr 2019 (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.
The purpose of this clinical investigation is to determine the safety and feasibility of detecting acoustic signals related to blood supply in subjects with acute large vessel occlusion (LVO) stroke by using the SONAS® device.
Detailed description
This clinical investigation will assess the performance of the SONAS® device in subjects with acute stroke admitted to the emergency department or stroke unit within 24 hours of symptoms onset and confirmed occlusion of either the proximal middle, distal M1-segment cerebral arteries, or distal internal carotid arteries (including carotid-T occlusion) by cerebral magnetic resonance imaging (cMRI) or cerebral imaging computed tomography (cCT), including perfusion weighted (pw) imaging sequences, will be considered for the investigation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental:Diagnostic | Experimental | Device: SONAS® Ultrasound DeviceDiagnostic Test: SONAS® Ultrasound Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent obtained
- Male or female subject ≥18 years
- Clinical diagnosis of acute stroke (NIHSS score: ≥10)
- Time of stroke symptoms onset: ≤24 hours
- Confirmed occlusion of either the proximal middle cerebral artery (occlusion of the proximal, middle or distal M1-segment) or the distal internal carotid artery (including carotid-T occlusion) by cMRI or cCT (including perfusion weighted imaging sequences)
Key exclusion criteria (24 listed)
- Subjects with known contraindications to the use of SonoVue®:
- Pregnant women
- Subjects with severe cardiac or pulmonary disease as defined by the treating physician
- Subjects with acute endocarditis and/or artificial heart valve
- Subjects with acute systemic inflammation and/or sepsis
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 |
|---|---|---|
| SONAS® Ultrasound DeviceThe SONAS® Ultrasound Device is intended for non-invasive transcranial ultrasound and used with a commercially approved contrast agent (e.g., Lumason®/SonoVue®). | Device | Experimental:Diagnostic |
Primary outcome
Assessment of Brain Perfusion
Time frame: 24 hours
Measurement of the kinetic parameter time to peak (TTP) in the right and left-brain hemisphere during the SONAS® test
Comparison
Time frame: 7 days
Comparison between SONAS® versus cMRI or cCT generated intra-individual differences in the parameter TTP in the right and left-brain hemisphere
Assessment of Adverse Events
Time frame: 72 hours
Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SONAS® Ultrasound Device in people with Stroke, Acute, run by Burl Concepts, Inc. at 2 sites in 2 countries.
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 9 inclusion and 24 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. 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 Andreas Cischek (+49 89 893 1190, andreas.cischek@fgk-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Brain Perfusion (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 1 Apr 2019.