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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NeuralBot Investigational System

About this trial

This is an interventional diagnostic trial for Embolic Stroke of Undetermined Source

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Barrow Neurological Institute
Providence Brain & Spine Institute
Providence St. Vincent Medical Center
CHI Memorial Hospital
The University of Tennessee Health Science Center
Houston Methodist Neurological Institute
Swedish Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NeuralBot Investigational System

Arm Description

Robotic TCD monitoring during bubble exam

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Percent detection of RLS/PFO compared to SOC Transesophageal Echocardiography

Percent agreement for detection of clinically significant shunts with robotic TCD vs TTE

Full Information

NCT ID

NCT04604015

First Posted

October 22, 2020

Last Updated

September 29, 2022

Sponsor

NovaSignal Corp.

1. Study Identification

Unique Protocol Identification Number

NCT04604015

Brief Title

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

Acronym

BUBL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

October 6, 2020 (Actual)

Primary Completion Date

October 20, 2021 (Actual)

Study Completion Date

November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NovaSignal Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Masking Description

All de-identified imaging data will be sent to a core laboratory which will provide independent quantitative and qualitative assessment of all NB-IS TCD and SOC TCD, TTE, and TEE bubble study data. They will be blinded to the study and local diagnostic report data and provide independent review. The Core Lab interpretations will supersede all local interpretations and will be applied to all study endpoint analyses as applicable.

Allocation

N/A

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NeuralBot Investigational System

Arm Type

Experimental

Arm Description

Robotic TCD monitoring during bubble exam

Intervention Type

Diagnostic Test

Intervention Name(s)

NeuralBot Investigational System

Other Intervention Name(s)

Lucid Robotic System, NovaGuide, Lucid TCD, NovaBot

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percent detection of RLS/PFO compared to standard of care (SOC) Transthoracic Echocardiography

Description

Target 40% increase in robotic transcranial Doppler ultrasound sensitivity compared to transthoracic echocardiography

Time Frame

1 to 60 days after subject receives robotic transcranial Doppler ultrasound bubble exam

Secondary Outcome Measure Information:

Title

Percent detection of RLS/PFO compared to SOC Transcranial Doppler Ultrasound

Description

Robotic TCD sensitivity greater than or equal to 90% compared to SOC TCD bubble exams

Time Frame

1 to 60 days after subject receives robotic transcranial Doppler ultrasound bubble exam

Title

Percent detection of RLS/PFO compared to SOC Transesophageal Echocardiography

Description

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

Title

Percent agreement for detection of clinically significant shunts with robotic TCD vs TTE

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrei Alexandrov, MD

Organizational Affiliation

The University of Tennessee Health Science Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mark Rubin, MD

Organizational Affiliation

The University of Tennessee Health Science Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barrow Neurological Institute

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Providence Brain & Spine Institute

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

Providence St. Vincent Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

CHI Memorial Hospital

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

The University of Tennessee Health Science Center

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38163

Country

United States

Facility Name

Houston Methodist Neurological Institute

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Swedish Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

12. IPD Sharing Statement

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

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