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

NovaSignal

Status: Completed

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04604015

NA-07BBL-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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154 participants in 1 patient group

NeuralBot Investigational System/TTE Std of Care

Experimental group

Description:

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

Treatment:

Diagnostic Test: NeuralBot Investigational System

Diagnostic Test: Transthoracic Echocardiography (TTE)