Embolic Stroke of Undetermined Source, Transient Ischemic Attack, Right-To-Left Atrial Shunt, Patent Foramen Ovale
Conditions
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.
Interventions
DIAGNOSTIC_TESTNeuralBot 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.
DIAGNOSTIC_TESTTransthoracic Echocardiography (TTE)
A test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events.
Sponsors
NovaSignal Corp.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
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 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.
Intervention 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 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device) | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 154 subjects were enrolled (signed Informed Consent), 129 evaluable and 121 completed the protocol.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 121 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Incomplete Data Collection | 33 |
Baseline characteristics
| Characteristic | NeuralBot Investigational System |
|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 14.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 103 Participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 63 Participants |
| Stroke diagnosis Absent transtemporal windows | 7 Participants |
| Stroke diagnosis Embolic stroke undetermined source | 68 Participants |
| Stroke diagnosis Other (not specificed) | 44 Participants |
| Stroke diagnosis Transient ischemic attack | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 121 |
| other Total, other adverse events | 0 / 121 | 0 / 121 |
| serious Total, serious adverse events | 0 / 121 | 0 / 121 |
Outcome results
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.
Time frame: 1 day
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NeuralBot Investigational System/TTE Std of Care | Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device) | NeuralBot Investigational System | Positive | 74 Participants |
| NeuralBot Investigational System/TTE Std of Care | Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device) | NeuralBot Investigational System | Negative | 47 Participants |
| NeuralBot Investigational System/TTE Std of Care | Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device) | TTE standard of care | Positive | 24 Participants |
| NeuralBot Investigational System/TTE Std of Care | Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device) | TTE standard of care | Negative | 97 Participants |
Comparison: The study was powered based on the results of a meta-analysis reporting the pooled NeuralBot (TCD) sensitivity for Right to Left Shunt detection, and the pooled TTE sensitivity for Right to Left Shunt detection.p-value: <0.00195% CI: [32.9, 50.2]McNemar