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RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt | Clinical Trials | Clareo Health

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

NCT04604015•NovaSignal Corp.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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

•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
•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

Key Dates

Start Date

October 6, 2020

Primary Completion Date

October 20, 2021

Completion Date

November 2, 2021

Last Updated

January 24, 2024

Enrollment

154

ACTUAL participants

Conditions

Embolic Stroke of Undetermined SourceTransient Ischemic AttackRight-To-Left Atrial ShuntPatent Foramen Ovale

Interventions

NeuralBot Investigational System

DIAGNOSTIC_TEST

Transthoracic Echocardiography (TTE)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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