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

NovaSignal Corp.154 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

154

Conditions

Embolic Stroke of Undetermined Source Transient Ischemic Attack Right-To-Left Atrial Shunt

Interventions

NeuralBot Investigational SystemDIAGNOSTIC_TEST

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.

Transthoracic Echocardiography (TTE)DIAGNOSTIC_TEST

A test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria TTE Main Study: 1. Subject 18 years of age and older. 2. 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. 3. Scheduled for a transthoracic echocardiograph (TTE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent. 4. Subject is able to successfully perform a Valsalva Maneuver (VM). 5. Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol. Exclusion Criteria TTE Main Study: 1. Subject has undergone a right to left shunt (RLS) or patent foramen ovale (PFO) closure. 2. Female who is pregnant or lactating at time of admission 3. Subjects who underwent partial or full craniotomy/craniectomy within the past 6 months. 4. Subjects who have a physical limitation preventing TCD headset placement Inclusion Criteria TEE Sub-Study (after first 150 subjects in Main TTE study enrolled): 1. Subject 18 years of age and older. 2. 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. 3. Scheduled for a transesophageal echocardiograph (TEE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent. 4. Subject is able to successfully perform a Valsalva Maneuver (VM). 5. 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): 1. Subject has undergone a right to left shunt (RLS) or patent foramen ovale (PFO) closure. 2. Female who is pregnant or lactating at time of admission 3. Subjects who underwent partial or full craniotomy/craniectomy within the past 6 months. 4. Subjects who have a physical limitation preventing TCD headset placement.

Locations (7)

Barrow Neurological Institute

Phoenix, Arizona, United States

Providence Brain & Spine Institute

Portland, Oregon, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

CHI Memorial Hospital

Chattanooga, Tennessee, United States

The University of Tennessee Health Science Center

Memphis, Tennessee, United States

Houston Methodist Neurological Institute

Houston, Texas, United States

Swedish Hospital

Seattle, Washington, United States

Outcomes

Primary Outcomes

Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device)

The primary outcome measure was the percent detection of Right to Left Shunt using the robotic assisted TCD (study device) and compare it to the percent detection of Right to Left Shunt using standard of care Transthoracic Echocardiography (TTE) for the same patient cohort. The detection of the Right to Left Shunt included site and independent Core Lab assessment of TTE.

Time frame: 1 day