Study: SONAS Ultrasound for Detecting Stroke SONAS Ultrasound for Detecting Stroke

• Status: Completed
• Trial end date: 2019-01-20
• Target enrollment: 0
• Participant gender: All

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, such as emergency vehicles (eg. ambulances, helicopters). To demonstrate the safety of the device the goal is test it in a small number of healthy volunteers first.

The SONAS device will be used to detect changes in blood flow to the brain through ultrasound, otherwise known as TransCranial Doppler (TCD). To date, the SONAS device has been tested extensively in the laboratory, in animals and in human cadavers. The purpose of the present study is to test the device for safety and efficacy in a small group of healthy volunteers. This study will test the device on 10 healthy volunteers. Each volunteer will have a physical examination, neurological examination, and brain MRI both before and after the TCD test is performed. All of these study procedures will be performed on 1 visit, lasting approximately 5 hours. The brain MRI's will be used to verify the effectiveness of the SONAS device on detecting changes in blood flow to the brain.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborators: BURL Concepts Inc.; Burl Concepts, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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:

1. Macrogol 4000

2. Distearoylphosphatidylcholine

3. Dipalmitoylphosphatidylglycerol

4. 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