STTR Phase I: SondeFlux, a novel, low-cost, noninvasive device to detect and characterize the presence or absence of a bolus in the upper esophagus.

The broader impacts/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to investigate novel noninvasive methods for detecting and quantifying material in the upper esophagus. Reflux occurs when a bolus of gastric contents flows in reverse from the stomach into the esophagus. Symptoms of reflux can include chronic cough, choking, difficulty breathing or swallowing, upper airway infections, and chest pain, but these symptoms can also be associated with other serious medical conditions. The proposed technology will aid clinicians in quickly assessing a patient’s symptoms to determine if reflux is the underlying cause. A noninvasive diagnostic modality for assessing reflux could save the healthcare system $10 billion annually, allow clinicians to provide improved care to their patients, and reduce the out-of-pocket costs to the 80 million Americans who are affected by reflux-related symptoms. The proposed STTR Phase I project will advance a technology using pulse-echo ultrasound and proprietary algorithms in a new non-conventional way to create an acoustic signature that can detect and differentiate a bolus in the esophagus. The esophagus distends in response to a bolus of material, eliciting the esophageal layers to change with respect to one another. Those changes can be observed with ultrasound sensors placed externally on the skin. This project will develop and validate electronic hardware, software, and custom ultrasonic transducers. This data acquisition system will be used to collect pulse-echo ultrasound data in an approved clinical early feasibility study. Data will be collected from patients undergoing modified barium swallow studies. The ultrasound data will be synchronized with the video-fluoroscopic images allowing for the development of a classifier algorithm which can automatically detect when a bolus is present at the level of the upper esophageal sphincter (UES). This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.