Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03897153
Other study ID # SONAS2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 12, 2019
Est. completion date October 2019

Study information

Verified date March 2019
Source Burl Concepts, Inc.
Contact Andreas Cischek
Phone +49 89 893 1190
Email andreas.cischek@fgk-cro.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Written informed consent obtained

2. Male or female subject =18 years

3. Clinical diagnosis of acute stroke (NIHSS score: =10)

4. Time of stroke symptoms onset: =24 hours

5. 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)

6. Women of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin result, obtained within 24 hours before administration of SonoVue®

7. 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

Exclusion Criteria:

1. 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

- Distearoylphosphatidylcholine

- Dipalmitoylphosphatidylglycerol sodium

- Palmitic acid

2. Pregnant women

3. Subjects with severe cardiac or pulmonary disease as defined by the treating physician

4. Subjects with acute endocarditis and/or artificial heart valve

5. Subjects with acute systemic inflammation and/or sepsis

6. Subjects with hyperactive coagulation states and/or a recent thromboembolism

7. Subjects with end stage renal or hepatic disease

8. 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

9. Subjects with known implanted deep brain stimulation devices

10. 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

11. 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

12. Subjects with axial (coronal) skull diameters of <12 cm or >18 cm

13. 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

14. Previous participation in this clinical investigation

15. 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

16. Subjects committed to an institution by an order issued either by the courts or by an authority

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SONAS® Ultrasound Device
The SONAS® Ultrasound Device is intended for non-invasive transcranial ultrasound and used with a commercially approved contrast agent (e.g., Lumason®/SonoVue®).

Locations

Country Name City State
Austria Universitätsklinik für Neurologie / Medizinische Universität Wien Vienna
Germany Universitätsklinik für Neurologie / Universitätsklinikum Regensburg Regensburg

Sponsors (1)

Lead Sponsor Collaborator
Burl Concepts, Inc.

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of Brain Perfusion Measurement of the kinetic parameter time to peak (TTP) in the right and left-brain hemisphere during the SONAS® test 24 hours
Primary Comparison Comparison between SONAS® versus cMRI or cCT generated intra-individual differences in the parameter TTP in the right and left-brain hemisphere 7 days
Primary 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 72 hours
See also
  Status Clinical Trial Phase
Recruiting NCT05378035 - DOAC in Chinese Patients With Atrial Fibrillation
Completed NCT03574038 - Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke N/A
Completed NCT03679637 - Tablet-based Aphasia Therapy in the Acute Phase After Stroke N/A
Completed NCT03633422 - Evaluation of Stroke Patient Screening
Completed NCT04088578 - VNS-supplemented Motor Retraining After Stroke N/A
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Not yet recruiting NCT05534360 - Tenecteplase Treatment in Ischemic Stroke Registry
Not yet recruiting NCT04105322 - Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients N/A
Withdrawn NCT05786170 - ERILs Und SNILs Unter SOC N/A
Recruiting NCT03132558 - Contrast Induced Acute Kidney in Patients With Acute Stroke N/A
Completed NCT02893631 - Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke
Active, not recruiting NCT02274727 - Biomarker Signature of Stroke Aetiology Study: The BIOSIGNAL-Study
Completed NCT02225730 - Imaging Collaterals in Acute Stroke (iCAS)
Terminated NCT01705353 - The Role of HMGB-1 in Chronic Stroke N/A
Active, not recruiting NCT01581502 - SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF) N/A
Completed NCT01182818 - Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease N/A
Completed NCT00761982 - Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment. Phase 1/Phase 2
Completed NCT00535197 - Autologous Bone Marrow Stem Cells in Ischemic Stroke. Phase 1/Phase 2
Terminated NCT00132509 - FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke Phase 2
Recruiting NCT05760326 - Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients