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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuralBot Investigational System/TTE Std of Care | Experimental | Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria TTE Main Study:
Exclusion Criteria TTE Main Study:
Inclusion Criteria TEE Sub-Study (after first 150 subjects in Main TTE study enrolled):
Exclusion Criteria TEE Sub-Study (after first 150 subjects in Main TTE study enrolled):
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Alexandrov, MD | The University of Tennessee Health Science Center | Study Chair |
| Mark Rubin, MD | The University of Tennessee Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Providence Brain & Spine Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37795589 | Result | Rubin MN, Shah R, Devlin T, Youn TS, Waters MF, Volpi JJ, Stayman A, Douville CM, Lowenkopf T, Tsivgoulis G, Alexandrov AV. Robot-Assisted Transcranial Doppler Versus Transthoracic Echocardiography for Right to Left Shunt Detection. Stroke. 2023 Nov;54(11):2842-2850. doi: 10.1161/STROKEAHA.123.043380. Epub 2023 Oct 5. |
| Label | URL |
|---|---|
| Robot-Assisted Transcranial Doppler Versus Transthoracic Echocardiography for Right to Left Shunt Detection | View source |
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A total of 154 subjects were enrolled (signed Informed Consent), 129 evaluable and 121 completed the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | NeuralBot Investigational System/TTE Std of Care | Subjects presented with suspected embolic cerebrovascular event, were scanned by both devices within 30 days of the index scan. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2021 |
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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 Head mounted 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.
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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 Standard of care (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.
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| Transthoracic Echocardiography (TTE) | Diagnostic Test | A test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events. |
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| Portland |
| Oregon |
| 97225 |
| United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| CHI Memorial Hospital | Chattanooga | Tennessee | 37404 | United States |
| The University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| Houston Methodist Neurological Institute | Houston | Texas | 77030 | United States |
| Swedish Hospital | Seattle | Washington | 98122 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Per Protocol/Completed subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | NeuralBot Investigational System | Robotic TCD monitoring during bubble exam NeuralBot Investigational System: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Stroke diagnosis | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1 day |
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Device related adverse events were collected during the period of device use (1 Day)
Device related events (only) were collected during the period of device use.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NeuralBot Investigational System | Investigational Robotic Transcranial Doppler (TCD) NeuralBot Investigational System: 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. | 0 | 121 | 0 | 121 | 0 | 121 |
| EG001 | TTE Std of Care | Control Device- Transthoracic Echocardiography Transthoracic Echocardiography (TTE): A test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events. | 0 | 121 | 0 | 121 | 0 | 121 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manja Lenkin | NovaSignal | 8776387251 | manja.lenkin@novasignal.com |
| Nov 16, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002546 | Ischemic Attack, Transient |
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Other (not specificed) |
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| Absent transtemporal windows |
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| Negative |
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