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Evaluation of the SONAS® Ultrasound Device for the Assessment of Bilateral Cerebral Perfusion in Subjects With Acute Stroke

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ClinicalTrials.gov Identifier: NCT03897153
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Burl Concepts, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Device: SONAS® Ultrasound Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the SONAS® Ultrasound Device for the Assessment of Bilateral Cerebral Perfusion in Subjects With Acute Stroke
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Experimental:Diagnostic
Diagnostic Test: SONAS® Ultrasound Device
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®).




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897153


Contacts
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Contact: Andreas Cischek +49 89 893 1190 andreas.cischek@fgk-cro.com
Contact: Thilo Hoelscher, MD 619-277-3702 thilo@burlconcepts.com

Locations
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Austria
Universitätsklinik für Neurologie / Medizinische Universität Wien Not yet recruiting
Vienna, Austria, 1090
Contact: Sonja Wieszmüllner    +43(1) 404 00-31210      
Principal Investigator: Assoc. Prof. Priv. Doz. Dr. Stefan Greisenegger         
Germany
Universitätsklinik für Neurologie / Universitätsklinikum Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Claudia Koeppl    +49 941 941 3502    claudia.koeppl@medbo.de   
Principal Investigator: Prof. Christian Stroszczynski, MD         
Sponsors and Collaborators
Burl Concepts, Inc.

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Responsible Party: Burl Concepts, Inc.
ClinicalTrials.gov Identifier: NCT03897153     History of Changes
Other Study ID Numbers: SONAS2018
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Burl Concepts, Inc.:
Stroke, Acute
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases