NovSignal NA-07BBL-01 BUBL
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
The purpose of this research study is to compare the use of a robotic headset, referred to as the NeuralBot Investigational System (NB-IS), to possibly detect a RLS or PFO against the standard of care diagnostic procedures you are scheduled to receive. The robotic TCD scan bubble exam will be performed in addition to these standard of care diagnostic procedures.
This is a research study to test a new investigational device, the NeuralBot Investigational System (NB-IS). An investigational device is one that is not approved by the United States Food and Drug Administration (FDA). The investigational device will be used in conjunction with the Lucid M1 System, an FDA-approved TCD ultrasound device. The use of the Lucid M1 System with or without the investigational device in this study is not for the purposes of diagnosis. This device is being used solely for research to develop technology for automated TCD ultrasound measurements.