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

Not Applicable

Completed

• Conditions: Patent Foramen Ovale; Transient Ischemic Attack; Right-To-Left Atrial Shunt; Embolic Stroke of Undetermined Source
• Interventions: Diagnostic Test: NeuralBot Investigational System; Diagnostic Test: Transthoracic Echocardiography (TTE)

• Registration Number: NCT04604015
• Lead Sponsor: NovaSignal Corp.

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.

Study Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-25
• Study First Posted: 2020-10-27
• Primary Completion: 2021-10-20
• Study Completion: 2021-11-02
• Results First Submitted: 2023-11-16
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-28
• Last Update Submitted: 2023-12-28
• Results First Posted: 2024-01-24
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NeuralBot Investigational System/TTE Std of Care	NeuralBot Investigational System	Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care
NeuralBot Investigational System/TTE Std of Care	Transthoracic Echocardiography (TTE)	Investigational Robotic Transcranial Doppler (TCD)/TTE Std of Care

Primary Outcome Measures

Name	Time	Method
Percent Detection of Right to Left Shunt (RLS)/Patent Foramen Ovale (PFO) Using Robotic Assisted TCD (Study Device)	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.

Trial Locations

Locations (7)

CHI Memorial Hospital; 🇺🇸 Chattanooga, Tennessee, United States

Houston Methodist Neurological Institute; 🇺🇸 Houston, Texas, United States

Swedish Hospital; 🇺🇸 Seattle, Washington, United States

Providence Brain & Spine Institute; 🇺🇸 Portland, Oregon, United States

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

Providence St. Vincent Medical Center; 🇺🇸 Portland, Oregon, United States

The University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States