NCT07009873招募中不适用
Clinical Application on the R&D Purpose of Wearable Ultrasound Sensors:A Single-Center Prospective Study
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年8月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Image Quality
研究概览
简要总结
This study aims to develop and evaluate a wearable ultrasound imaging sensor for the early diagnosis and real-time monitoring of various diseases, such as cardiovascular conditions and structural abnormalities of superficial organs. With advancements in medical technology, wearable devices have attracted increasing attention for their portability and real-time capabilities.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 yrs and able to consent
- •Relevant diagnosis for study arm (heart failure, lower-limb DVT, or ICU monitoring)
- •Adequate acoustic window and intact skin at sensor site
- •Arm-specific:
- •Heart-failure arm: Clinically stable HFrEF or HFpEF on standard therapy
- •DVT arm: Imaging-confirmed lower-limb DVT, anticoagulated or scheduled for intervention
- •ICU arm: ICU/post-op patient requiring continuous bedside ultrasound
排除标准
- •Poor acoustic window preventing interpretable images
- •Local skin infection, open wound, or implant/hardware blocking sensor
- •Inability to cooperate with monitoring
- •Arm-specific:
- •Heart-failure arm: Acute MI or uncontrolled arrhythmia in past 3 months
- •DVT arm: Active bleeding or severe coagulopathy
- •ICU arm: Unstable multi-organ failure precluding safe monitoring
结局指标
主要结局
Image Quality
时间窗: Day 1 (Baseline): Measured immediately after first wearable sensor placement
* Signal-to-Noise Ratio (SNR) * Unit: decibels (dB) * Contrast-to-Noise Ratio (CNR) * Unit: decibels (dB)
次要结局
- Consistency of image quality(Day 1 (Baseline): Measured during the initial imaging session)
- Consistency of image quality(Day 1 (Baseline): Measured immediately after first wearable sensor placement)
研究者
Yu-kun Luo
Clinical Professor
Chinese PLA General Hospital
研究点 (1)
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