RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt

NCT04604015 | Completed Results FDA Device

• 1 other identifier: NA-07BBL-01
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 7

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.

Conditions

Embolic Stroke of Undetermined Source; Transient Ischemic Attack; Right-To-Left Atrial Shunt; Patent Foramen Ovale

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

NeuralBot Investigational System/TTE Std of Care

EXPERIMENTAL

Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care

Diagnostic Test: NeuralBot Investigational System; Diagnostic Test: Transthoracic Echocardiography (TTE)

Interventions

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.

Also known as: Lucid Robotic System, NovaGuide, Lucid TCD, NovaBot

NeuralBot Investigational System/TTE Std of Care

Transthoracic Echocardiography (TTE) DIAGNOSTIC_TEST

A test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events.

Also known as: TTE

NeuralBot Investigational System/TTE Std of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• NovaSignal Corp.: lead

Study Sites (7)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Providence Brain & Spine Institute

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

CHI Memorial Hospital

Chattanooga, Tennessee, 37404, United States

Location

The University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

Swedish Hospital

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• 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.

  PMID: 37795589 RESULT

Related Links

• Robot-Assisted Transcranial Doppler Versus Transthoracic Echocardiography for Right to Left Shunt Detection

MeSH Terms

Conditions

Ischemic Attack, Transient; Foramen Ovale, Patent

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Results Point of Contact

• Title: Manja Lenkin
• Organization: NovaSignal

manja.lenkin@novasignal.com

8776387251

Study Officials

• Andrei Alexandrov, MD

  The University of Tennessee Health Science Center

  STUDY CHAIR

• Mark Rubin, MD

  The University of Tennessee Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 27, 2020
• Study Start: October 6, 2020
• Primary Completion: October 20, 2021
• Study Completion: November 2, 2021
• Last Updated: January 24, 2024
• Results First Posted: January 24, 2024

Record last verified: 2023-12

Locations

US (7)