NCT04604015

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: NovaSignal Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
DIAGNOSTIC_TEST	Transthoracic Echocardiography (TTE)	A test that uses ultrasound to create a hemodynamic assessment for major cardiovascular events.

Timeline

• Start date: 2020-10-06
• Primary completion: 2021-10-20
• Completion: 2021-11-02
• First posted: 2020-10-27
• Last updated: 2024-01-24
• Results posted: 2024-01-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study