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.

这项小型企业技术转移（STTR）第一阶段项目的更广泛的影响和商业潜力是研究用于检测和量化上食管物质的新型无创方法。当胃内容物从胃反流到食道时，就会发生反流。反流的症状包括慢性咳嗽、窒息、呼吸或吞咽困难、上呼吸道感染和胸痛，但这些症状也可能与其他严重的疾病有关。这项提议的技术将帮助临床医生快速评估病人的症状，以确定反流是否是潜在的原因。一种评估反流的无创诊断方式每年可以为医疗保健系统节省100亿美元，使临床医生能够为患者提供更好的护理，并减少8000万受反流相关症状影响的美国人的自付费用。拟议的STTR一期项目将推进一项使用脉冲回波超声和专有算法的技术，以一种新的非常规方式创建声学特征，可以检测和区分食道中的丸剂。食道因大量物质而膨胀，引起食道各层相对变化。这些变化可以通过放置在皮肤外部的超声波传感器观察到。该项目将开发和验证电子硬件、软件和定制超声波换能器。该数据采集系统将用于收集经批准的临床早期可行性研究中的脉冲回波超声数据。数据将从接受改良钡吞入研究的患者中收集。超声数据将与视频透视图像同步，以便开发一种分类算法，该算法可以自动检测出丸何时出现在食管上括约肌（UES）的水平。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.