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Cervix monitor for risk assessment of spontaneous preterm delivery

宫颈监测仪用于评估自然早产的风险

基本信息

批准号：
9255116
负责人：
Vladimir Egorov
金额：
$ 22.5万
依托单位：
ADVANCED TACTILE IMAGING, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-22 至 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9255116
关键词：
2 year old 5 year old Agreement Algorithms Biochemical Markers Biological Markers Breast Cause of Death Cervical Cervix Uteri Child Clinical Clinical Research Clinical Treatment Computer software Country Coupling Data Detection Development Devices Elasticity Electromagnetics Failure Female Goals Grant Healthcare Imaging Device Imaging technology Infant Intervention Legal patent Length Magnetism Measurement Mechanics Medical Monitor Muscle Neonatal Mortality Pelvic floor structure Performance Phase Pregnancy Pregnancy Complications Premature Birth Preventive Procedures Prostate Protocols documentation Publishing Reporting Reproducibility Risk Risk Assessment Risk Factors Safety Secure Software Design Stress System Tactile Technology Testing TimeLine Tissue Model Tissues Training Ultrasonic Transducer Ultrasonography United States National Institutes of Health Vagina Validation Visual Wireless Technology Woman base biomaterial compatibility clinical practice cost effective data acquisition design diagnostic accuracy digital elastography imaging system infant morbidity/mortality innovation interest meetings neonatal death pregnant premature pressure prototype sensor software development targeted treatment transmission process usability

项目摘要

Currently, spontaneous preterm delivery (SPTD) is the leading global cause of infant mortality and morbidity. In most countries, the rate of preterm births has risen in recent decades and now represents the largest cause of neonatal death and the second largest direct cause of death in children under five. Discovering how to lower the rate of this major complication of pregnancy should be one of the highest priorities in contemporary health care and detection of premature maturation of cervix is a promising way to reduce the likelihood of SPTD. In Phase I, we propose to design a prototype of the Cervix Monitor (CM) with a single use probe comprised of a tactile sensor array and an ultrasound transducer for cervix elasticity and length measurements. The device will be based on our patented technology. After safety and electromagnetic compatibility testing and bench verification, we plan a pilot clinical study to assess CM performance with 10 pregnant and 10 non-pregnant women. The long term objective of the project is to bring a compact, cost-effective and easy-to-use device for risk assessment of SPTD into clinical practice.

目前，自发性早产（SPTD）是全球婴儿死亡的主要原因和发病率。在大多数国家，近几十年来早产率有所上升，是新生儿死亡的最大原因，也是新生儿死亡的第二大直接原因。五岁以下儿童。发现如何降低这一主要妊娠并发症的发生率应该是当代卫生保健和早产儿检测的最高优先事项之一。子宫颈的成熟是降低SPTD可能性的有希望的方法。在第一阶段，我们建议设计带有一次性探头的Cerebral Monitor（CM）原型，包括触觉传感器阵列和用于子宫颈弹性和长度的超声换能器测量.该设备将基于我们的专利技术。在安全和电磁兼容性测试和台架验证，我们计划进行试点临床研究，评估10名孕妇和10名非孕妇的CM性能。长期目标该项目的目的是带来一个紧凑，具有成本效益和易于使用的设备进行风险评估， SPTD应用于临床实践。