NCT03897153

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Burl Concepts, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
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®).

Timeline

• Start date: 2019-02-12
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2019-04-01
• Last updated: 2019-04-01

Locations

2 sites across 2 countries: Austria, Germany