RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
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).
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.
Inclusion Criteria:

 1. Subject 18 to 60 years of age.

 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:

 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