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Trial record 1 of 2 for:    SONAS
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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.

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE February 12, 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the SONAS® Ultrasound Device for the Assessment of Bilateral Cerebral Perfusion in Subjects With Acute Stroke
Official Title  ICMJE Evaluation of the SONAS® Ultrasound Device for the Assessment of Bilateral Cerebral Perfusion in Subjects With Acute Stroke
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Stroke, Acute
Intervention  ICMJE 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®).
Study Arms  ICMJE Experimental: Experimental:Diagnostic
Diagnostic Test: SONAS® Ultrasound Device
Intervention: Device: SONAS® Ultrasound Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andreas Cischek +49 89 893 1190 andreas.cischek@fgk-cro.com
Contact: Thilo Hoelscher, MD 619-277-3702 thilo@burlconcepts.com
Listed Location Countries  ICMJE Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03897153
Other Study ID Numbers  ICMJE SONAS2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Burl Concepts, Inc.
Study Sponsor  ICMJE Burl Concepts, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Burl Concepts, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP