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

Transient Ischemic Attack Clinical Trial

— BUBL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04604015
• Other study ID #: NA-07BBL-01
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

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

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

External Links

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