RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt

Study Overview
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Brief Summary
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This study is a multi-center, prospective, single-arm, non-significant risk (NSR) device study in which up to 150 evaluable subjects with suspicion of embolic stroke of undetermined source (ESUS) will be evaluated with NB-IS TCD and standard of care TTE to screen for right to left shunt (RLS) or patent foramen ovale (PFO). Additionally, up to 150 evaluable subjects will be evaluated with NB-IS TCD and standard of care TEE.

Detailed Description
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The objectives of the study is to evaluate the shunt detection rate of the NeuralBot Investigational System (NB-IS) TCD relative to standard of care diagnostic techniques (transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and standard transcranial Doppler ultrasound (TCD) and to assess the safety, accuracy and usability of the NB-IS device.

Official Title
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RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt

Conditions
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Embolic Stroke of Undetermined Source, Transient Ischemic Attack, Right-To-Left Atrial Shunt, Patent Foramen Ovale

Intervention / Treatment
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* Diagnostic Test: NeuralBot Investigational System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria TTE Main Study: Subject 18 years of age and older. Subject presents with a clinical condition characterized by neurological signs and symptoms that, in the opinion of the investigator, include embolic stroke or transient ischemic attack (TIA) in the differential diagnosis. Scheduled for a transthoracic echocardiograph (TTE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent. Subject is able to successfully perform a Valsalva Maneuver (VM). Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol. Exclusion Criteria TTE Main Study: Subject has undergone a right to left shunt (RLS) or patent foramen ovale (PFO) closure. Female who is pregnant or lactating at time of admission Subjects who underwent partial or full craniotomy/craniectomy within the past 6 months. Subjects who have a physical limitation preventing TCD headset placement Inclusion Criteria TEE Sub-Study (after first 150 subjects in Main TTE study enrolled): Subject 18 years of age and older. Subject presents with a clinical condition characterized by neurological signs and symptoms that, in the opinion of the investigator, include embolic stroke or TIA in the differential diagnosis. Scheduled for a transesophageal echocardiograph (TEE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent. Subject is able to successfully perform a Valsalva Maneuver (VM). Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol. Exclusion Criteria TEE Sub-Study (after first 150 subjects in Main TTE study enrolled): Subject has undergone a right to left shunt (RLS) or patent foramen ovale (PFO) closure. Female who is pregnant or lactating at time of admission Subjects who underwent partial or full craniotomy/craniectomy within the past 6 months. Subjects who have a physical limitation preventing TCD headset placement.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The NeuralBot Investigational System is comprised of both the Lucid M1 System and the NeuralBot accessory. The NeuralBot accessory must be used with the Lucid M1 System and cannot operate independently. The NB-IS is a modification of a 510k cleared device called NeuralBot Guided Headmount Accessory (K180455;22May2018). The NeuralBot Investigational System is the investigational study device used in this study. The NeuralBot Investigational System (NB-IS) moves two ultrasound probes around the two temporal regions (Right and Left) of the head to find the transtemporal window and then optimizes cerebral blood flow velocity (CBFV) measurements. The system uses TCD data to systematically specify and evaluate probe positions. The NeuralBot Investigational System consists of a head-support structure that houses two probe positioning modules, a robotic controller unit and computer tablets. The NeuralBot Investigational System is non-invasive and does not deliver energy into a subject.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuralBot Investigational System<br>Robotic TCD monitoring during bubble exam | Diagnostic Test: NeuralBot Investigational System<br>* The NeuralBot Investigational System when used with the Lucid M1 System is a medical ultrasound device which assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the blood stream.<br>* Other names: NovaBot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent detection of RLS/PFO compared to standard of care (SOC) Transthoracic Echocardiography | Target 40% increase in robotic transcranial Doppler ultrasound sensitivity compared to transthoracic echocardiography | 1 to 60 days after subject receives robotic transcranial Doppler ultrasound bubble exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent detection of RLS/PFO compared to SOC Transcranial Doppler Ultrasound | Robotic TCD sensitivity greater than or equal to 90% compared to SOC TCD bubble exams | 1 to 60 days after subject receives robotic transcranial Doppler ultrasound bubble exam | 
| Percent detection of RLS/PFO compared to SOC Transesophageal Echocardiography | Percent detection of RLS/PFO compared to SOC Transesophageal Echocardiography | 1 to 60 days after subject receives robotic transcranial Doppler ultrasound bubble exam | 
| Percent agreement for detection of clinically significant shunts with robotic TCD vs TTE | Percent agreement for detection of clinically significant shunts with robotic TCD vs TTE | 1 to 60 days after subject receives robotic transcranial Doppler ultrasound bubble exam |