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

December 28, 2023 updated by: NovaSignal Corp.
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Brain & Spine Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • CHI Memorial Hospital
      • Memphis, Tennessee, United States, 38163
        • The University of Tennessee Health Science Center
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Neurological Institute
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeuralBot Investigational System/TTE Std of Care
Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care
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
A test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events.
Other Names:
  • TTE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent detection of RLS/PFO compared to SOC Transcranial Doppler Ultrasound
Time Frame: 1 to 60 days after subject receives robotic transcranial Doppler ultrasound bubble exam
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
Time Frame: 1 to 60 days after subject receives robotic transcranial Doppler ultrasound bubble exam
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
Time Frame: 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
1 to 60 days after subject receives robotic transcranial Doppler ultrasound bubble exam

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Andrei Alexandrov, MD, The University of Tennessee Health Science Center
  • Principal Investigator: Mark Rubin, MD, The University of Tennessee Health Science Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2020

Primary Completion (Actual)

October 20, 2021

Study Completion (Actual)

November 2, 2021

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 25, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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