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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04604015
Other study ID # NA-07BBL-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 6, 2020
Est. completion date November 2, 2021

Study information

Verified date December 2023
Source NovaSignal Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 (PFO). Additionally, up to 150 evaluable subjects will be evaluated with NB-IS TCD and standard of care TEE.


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.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date November 2, 2021
Est. primary completion date October 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
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.
Transthoracic Echocardiography (TTE)
A test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events.

Locations

Country Name City State
United States CHI Memorial Hospital Chattanooga Tennessee
United States Houston Methodist Neurological Institute Houston Texas
United States The University of Tennessee Health Science Center Memphis Tennessee
United States Barrow Neurological Institute Phoenix Arizona
United States Providence Brain & Spine Institute Portland Oregon
United States Providence St. Vincent Medical Center Portland Oregon
United States Swedish Hospital Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
NovaSignal Corp.

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. 1 day
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