Clinical trial NCT04604015: RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
Official title: RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embolic Stroke of Undetermined Source
Transient Ischemic Attack
Right-To-Left Atrial Shunt
Patent Foramen Ovale
Lead sponsor: NovaSignal Corp.
Sponsor class: INDUSTRY
First posted: 2020-10-27
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Exclusion Criteria TEE Sub-Study (after first 150 subjects in Main TTE study enrolled):

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.

Primary outcomes:
measure: Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Portland
country: United States
facility: Providence Brain & Spine Institute
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Chattanooga
country: United States
facility: CHI Memorial Hospital
state: Tennessee
city: Memphis
country: United States
facility: The University of Tennessee Health Science Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Neurological Institute
state: Texas
city: Seattle
country: United States
facility: Swedish Hospital
state: Washington
Study officials:
affiliation: The University of Tennessee Health Science Center
name: Andrei Alexandrov, MD
role: STUDY_CHAIR
affiliation: The University of Tennessee Health Science Center
name: Mark Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.