Embolic Stroke of Undetermined SourceBUBLNCT04604015
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
A study testing NeuralBot Investigational System and Transthoracic Echocardiography (TTE) in people with Embolic Stroke of Undetermined Source and Transient Ischemic Attack, run by NeuraSignal Inc dba NovaSignal at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Embolic Stroke of Undetermined Source, Transient Ischemic Attack, Right-To-Left Atrial Shunt
- What is being tested?
- NeuralBot Investigational System and Transthoracic Echocardiography (TTE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Oct 2020to 2 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
CHI Memorial Hospital
Chattanooga, Tennessee, 37404
Houston Methodist Neurological Institute
Houston, Texas, 77030
The University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Barrow Neurological Institute
Phoenix, Arizona, 85013
Providence Brain & Spine Institute
Portland, Oregon, 97225
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Swedish Hospital
Seattle, Washington, 98122
About this study
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.
Read the 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.
- Conditions
- Embolic Stroke of Undetermined Source, Transient Ischemic Attack, Right-To-Left Atrial Shunt, Patent Foramen Ovale
- Being tested
- NeuralBot Investigational System, Transthoracic Echocardiography (TTE)
- Medical subject headings
- Ischemic Attack, Transient, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuralBot Investigational SystemDiagnostic test
Also called Lucid Robotic System, NovaGuide, Lucid TCD, NovaBot
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.
Transthoracic Echocardiography (TTE)Diagnostic test
Also called TTE
A test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events.
| Study group | Role | What they receive |
|---|---|---|
| NeuralBot Investigational System/TTE Std of Care | Experimental | Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care Receives: Diagnostic Test: NeuralBot Investigational System; Diagnostic Test: Transthoracic Echocardiography (TTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start6 Oct 2020
- Primary completion20 Oct 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Embolic Stroke of Undetermined SourceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuraSignal Inc dba NovaSignal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrei Alexandrov, MD, Study chair, The University of Tennessee Health Science CenterMark Rubin, MD, Principal investigator, The University of Tennessee Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604015
- Sponsor's protocol ID
- NA-07BBL-01
- Acronym
- BUBL
- Status last verified
- Dec 2023
- First submitted
- 22 Oct 2020
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 37795589
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
- ClinicalTrials.gov ID
- NCT04604015
- Acronym / sponsor ID
- BUBL / NA-07BBL-01
- Conditions
- Embolic Stroke of Undetermined Source, Transient Ischemic Attack, Right-To-Left Atrial Shunt, Patent Foramen Ovale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- NeuraSignal Inc dba NovaSignalIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Posted 24 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| NeuralBot Investigational System/TTE Std of Care | Experimental | Diagnostic Test: NeuralBot Investigational System, Diagnostic Test: Transthoracic Echocardiography (TTE)Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
- Subject 18 years of age and older.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuralBot Investigational SystemAlso: Lucid Robotic System, NovaGuide, Lucid TCD, NovaBotThe 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 test | NeuralBot Investigational System/TTE Std of Care |
| Transthoracic Echocardiography (TTE)Also: TTEA test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events. | Diagnostic test | NeuralBot Investigational System/TTE Std of Care |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37795589Rubin 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.
- Robot-Assisted Transcranial Doppler Versus Transthoracic Echocardiography for Right to Left Shunt DetectionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Alexandrov, MD study chair
The University of Tennessee Health Science Center
Mark Rubin, MD principal investigator
The University of Tennessee Health Science Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuralBot Investigational System and Transthoracic Echocardiography (TTE) in people with Embolic Stroke of Undetermined Source and Transient Ischemic Attack, run by NeuraSignal Inc dba NovaSignal at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04604015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.