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.

STTR 第一阶段：SondeFlux，一种新型、低成本、无创设备，用于检测和表征上食道中是否存在食团。

• 批准号: 2002417
• 负责人: Bradley Stringer
• 金额: $ 22.5万
• 依托单位: REFLODX, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2021-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2002417&HistoricalAwards=false
• 关键词: STTR; Phase; SondeFlux; novel; low

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.

这个小型企业技术转移(STTR)第一阶段项目的更广泛的影响/商业潜力是研究新的非侵入性方法来检测和量化食道上部的物质。当胃内容物从胃反向流入食道时，就会发生反流。反流的症状可能包括慢性咳嗽、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医疗条件有关。这项拟议的技术将帮助临床医生快速评估患者的症状，以确定反流是否是根本原因。一种用于评估反流的非侵入性诊断方式每年可以为医疗系统节省100亿美元，允许临床医生为他们的患者提供更好的护理，并降低8000万受反流相关症状影响的美国人的自付费用。拟议的STTR第一阶段项目将以一种新的非传统方式推进一项使用脉冲回声超声和专有算法的技术，以创建一种可以检测和区分食道内团状物的声学特征。食道因一团物质的作用而膨胀，引起食管层之间的相互变化。这些变化可以通过放置在皮肤外部的超声波传感器来观察。该项目将开发和验证电子硬件、软件和定制的超声波换能器。该数据采集系统将用于在一项已获批准的临床早期可行性研究中收集脉冲回波超声数据。数据将从接受改良吞钡研究的患者那里收集。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上食道括约肌(UES)水平上的团注。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。