An interventional study of NeuralBot Investigational System and Transthoracic Echocardiography (TTE) in Embolic Stroke of Undetermined Source, Transient Ischemic Attack and Right-To-Left Atrial Shunt, sponsored by NovaSignal Corp.. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by NovaSignal Corp. · Not applicable, Interventional, and Diagnostic
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.
329 studies on the registry are indexed under Ischemic Attack, Transient; 71 are open to participants now.
This study's enrollment of 154 is below the median of 217 across 178 interventional studies indexed under Ischemic Attack, Transient.
Browse Ischemic Attack, Transient studies →NovaSignal Corp. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care
Diagnostic Test: NeuralBot Investigational System · Diagnostic Test: Transthoracic Echocardiography (TTE)
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.
Also known as: Lucid Robotic System, NovaGuide, Lucid TCD, NovaBot
A test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events.
Also known as: TTE
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
A total of 154 subjects were enrolled (signed Informed Consent), 129 evaluable and 121 completed the protocol.
| Milestone | NeuralBot Investigational System/TTE Std of Care |
|---|---|
| Started | 154 |
| Completed | 121 |
| Not completed | 33 |
| Withdrew: Incomplete data collection | 33 |
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.
| Participants | NeuralBot Investigational System/TTE Std of Care |
|---|---|
| NeuralBot Investigational System — Positive | 74 |
| NeuralBot Investigational System — Negative | 47 |
| TTE standard of care — Positive | 24 |
| TTE standard of care — Negative | 97 |
Collected over Device related adverse events were collected during the period of device use (1 Day). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NeuralBot Investigational System | 0/121 (0%) | 0/121 (0%) | 0/121 (0%) |
| TTE Std of Care | 0/121 (0%) | 0/121 (0%) | 0/121 (0%) |
Per Protocol/Completed subjects
| Age, Continuous(years) | NeuralBot Investigational System |
|---|---|
| Mean | 59.9 ± 14.7 |
| Sex: Female, Male(Participants) | NeuralBot Investigational System |
|---|---|
| Female | 58 |
| Male | 63 |
| Race (NIH/OMB)(Participants) | NeuralBot Investigational System |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 11 |
| White | 103 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
| Stroke diagnosis(Participants) | NeuralBot Investigational System |
|---|---|
| Embolic stroke undetermined source | 68 |
| Transient ischemic attack | 9 |
| Other (not specificed) | 44 |
| Absent transtemporal windows | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2020 to primary completion in Oct 2021, 12 months.
Results were first posted in Jan 2024, 2 years 3 months after primary completion.
Of 71 interventional studies with no phase under Ischemic Attack, Transient, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 72. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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