跳至主要内容
临床试验/NCT07270744
NCT07270744招募中不适用

Data Collection Using Eko Digital Devices in a Clinical Setting

Eko Devices, Inc.3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
3
主要终点
Primary Objective: Collection of Lung Sound Recordings to Explore Machine Learning Algorithm for Classifying Adventitious Lung Sounds

研究概览

简要总结

The main objectives of the study are to: train and validate binary classifiers for wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough, as well as determine correspondence between type/location of adventitious lung sound and type of pulmonary condition.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suspected or diagnosed lower respiratory condition OR Presence of wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough discovered during routine auscultation
  • Normal patients with no adventitious lung sounds
  • Adults patients, over 18 years old
  • Able to provide verbal consent

排除标准

  • Patients unable to have multiple recordings taken on chest and back (e.g. compromised mobility)
  • Patients on mechanical ventilation
  • Patients unwilling or unable to provide informed consent

结局指标

主要结局

Primary Objective: Collection of Lung Sound Recordings to Explore Machine Learning Algorithm for Classifying Adventitious Lung Sounds

时间窗: 14-15 months

The primary objective of this study is to collect normal and abnormal lung sounds of up to 750 patients per study site, by having clinicians use the Eko CORE and/or Eko CORE 500 device(s) in real clinical settings, as part of standard of care clinical practice which will then be used to explore an ML algorithm for classifiers for wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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