Completed

NCT Number: NCT04604015

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

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.

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Key information

Conditions

Embolic Stroke of Undetermined Source Brain Diseases Brain Ischemia Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Ischemic Attack, Transient Nervous System Diseases Patent Foramen Ovale Right-To-Left Atrial Shunt Transient Ischemic Attack Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barrow Neurological Institute, Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NeuralBot Investigational System

Diagnostic 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.

Other names: Lucid Robotic System, NovaGuide, Lucid TCD, NovaBot

Transthoracic Echocardiography (TTE)

Diagnostic Test

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

Other names: TTE

Primary outcomes

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

Time frame: 1 day

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.

Sponsors and collaborators

Lead sponsor

NeuraSignal Inc dba NovaSignal

Industry

Registry information

Acronym: BUBL

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Oct 27, 2020
Registry last updated: Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed