Status:
COMPLETED
Study: SONAS Ultrasound for Detecting Stroke SONAS Ultrasound for Detecting Stroke
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Burl Concepts, Inc.
Conditions:
Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this research study is to test a new medical device, called SONAS. The SONAS device is a portable, battery-powered ultrasound device to detect strokes in the prehospital environment, su...
Detailed Description
Specific Aims: Indicate the purpose of the research, specifying the problems and/or hypotheses to be addressed. Aim 1: Determine safety of the SONAS device Aim 1a: Obtain perfusion MRI (PWI) / quanti...
Eligibility Criteria
Inclusion
- Be at least 18 years of age
- No prior history of cerebro- or cardio-vascular disease
- Be willing to comply with study protocol
- Provide written informed consent
Exclusion
- Lumason™ is contraindicated in subjects known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension, and in subjects with adult respiratory distress syndrome.
- Lumason™ should not be used in combination with dobutamine in subjects with conditions suggesting cardiovascular instability where dobutamine is contraindicated.
- Lumason™ should not be used in subjects with known hypersensitivity to the following substances:
- Macrogol 4000
- Distearoylphosphatidylcholine
- Dipalmitoylphosphatidylglycerol
- Sodium Palmitic acid
- Female who is pregnant or a nursing mother (the possibility of pregnancy has to be excluded by negative serum or urine HCG results, obtained within 24 hours before Lumason™ administration, or on the basis patient history, e.g.: tubal ligation, hysterectomy, or a minimum of 1 year history without menses
- Contraindications to MRI, pregnancy, lactation, morbid obesity, and severe claustrophobia
- Known allergy to gadolinium
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03296852
Start Date
April 19 2018
End Date
January 20 2019
Last Update
March 26 2019
Active Locations (1)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095