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NCT03296852 · ClinicalTrials.gov registry record · Early Phase 1
Study: SONAS Ultrasound for Detecting Stroke SONAS Ultrasound for Detecting Stroke
A Early Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT03296852: Completed Early Phase 1 study, sponsored by University of California, Los Angeles.
NCT03296852 is a Early Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03296852, a Early Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
BBB impairment will be assessed by extravasation of Gadolinium into the brain tissue. Because of its molecular weight Gadolinium cannot enter the extravascular space, unless the BBB integrity is impaired. BBB impairment causes leakage of Gadolinium in into the extravascular space which, in turn, can be visualized by T1-weighted sequences.
Interventions
- DRUG Lumason
- DIAGNOSTIC_TEST SONAS Ultrasound Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-04-19 |
| Est. Completion | 2019-01-20 |
| Phase | Early Phase 1 |
What the finished NCT03296852 record still lists
NCT03296852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Lumason is the first listed.
NCT03296852 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03296852 about?
NCT03296852 is a clinical study titled "Study: SONAS Ultrasound for Detecting Stroke SONAS Ultrasound for Detecting Stroke". 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 ...
What is the current status of trial NCT03296852?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2018-04-19. Estimated completion is 2019-01-20.
What interventions are being tested in trial NCT03296852?
The interventions under investigation include: Lumason (DRUG), SONAS Ultrasound Device (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03296852?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03296852's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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