NovaSignal Clinical Trials

LARGE VESSEL OCCLUSION

Cerebral Blood Flow Velocity Morphology – Large Vessel Occlusion

Completed

Objective

To collect adequate quality data to develop an algorithmic framework for assessing cerebral vascular occlusions confirmed by standard of care Computer Tomography Angiography (CTA) imaging.

Design

Prospective, multi-center, multi-arm, multi-cohort

Number of Subjects

147

TRAUMATIC BRAIN INJURY

Advanced Morphological Analysis of Cerebral Blood Flow for Acute Concussion Diagnosis and Return-To-Play Determination.

Completed

Objective

To develop and evaluate an analytical platform for quantifying cerebral hemodynamic dysfunction following mild TBI and expand our medical and scientific understanding of these changes.

Design

Prospective, longitudinal, single-center, multi-arm, multi-cohort

Number of Subjects

219

INTRACRANIAL BLEED

Precision Intracranial Bleed Triage and Monitoring

enrolling

Objective

To determine if cerebral hemodynamic dysfunction can be used to rapidly classify traumatic brain injury and determine if the subject(s) are at risk of deteriorating.

Design

Prospective, multi-arm, multi-center, non-invasive

Number of Subjects

Up to 600

INTRACRANIAL PRESSURE

Cerebral Blood Flow Velocity Morphology for Quantification of Intracranial Pressure

enrolling

Objective

To collect high quality cerebral blood flow velocity (CBFV) measurements to develop an algorithmic framework to determine correlation to and estimates of intracranial pressure when measured with invasive monitoring.

Design

Prospective, multi-center, multi cohort, non-invasive

Number of Subjects

Up to 540

PFO

NovaGuide Intelligent Ultrasound Compared to Transthoracic Echocardiography for Detection of Right-to-Left Shunt

enrolling

Objective

To evaluate the shunt detection rate of the NovaGuide Intelligent Ultrasound relative to standard of care diagnostic techniques (TTE, TEE, SOC TCD), and to assess the safety, accuracy and usability of the device.

Design

Prospective, single-arm multi-center, non-significant risk

Number of Subjects

Up to 150

We’ve been awarded over $25M in research grants from the DoD, NIH, and NSF

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