Clinical Application of Wearable Ultrasound Sensors

Chinese PLA General Hospital300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

DVT - Deep Vein Thrombosis POCUS

Interventions

This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.OTHER

This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Image Quality

* Signal-to-Noise Ratio (SNR) * Unit: decibels (dB) * Contrast-to-Noise Ratio (CNR) * Unit: decibels (dB)

Time frame: Day 1 (Baseline): Measured immediately after first wearable sensor placement

Image Quality

* Axial Resolution * Unit: millimeters (mm) * Lateral Resolution * Unit: millimeters (mm)

Time frame: Day 1 (Baseline): Measured immediately after first wearable sensor placement

Secondary Outcomes

Consistency of image quality

Image Clarity Score Unit: 5-point Likert scale (1 = poor to 5 = excellent)

Time frame: Day 1 (Baseline): Measured immediately after first wearable sensor placement

Consistency of image quality

Intra-session Reproducibility of SNR Unit: Intraclass correlation coefficient (ICC)

Time frame: Day 1 (Baseline): Measured during the initial imaging session

Consistency of image quality

Diagnostic Sensitivity Unit: percent (%)

Time frame: Day 1 (Baseline): Measured during the initial imaging session

Central Contacts

Yuyang Li, PhD

CONTACT

+86 0451-86412296 248597504@qq.com

Data from ClinicalTrials.gov

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