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NCT Number: NCT07009873

Clinical Application of Wearable Ultrasound Sensors

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.

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Key information

Conditions

DVT - Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis POCUS Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Jia Zhang

CONTACT

[email protected]

+86 13262211459

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Image Quality

    Time frame: 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)

  2. Image Quality

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

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

Secondary outcomes

  1. Consistency of image quality

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

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

  2. Consistency of image quality

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

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

  3. Consistency of image quality

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

    Diagnostic Sensitivity Unit: percent (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Yuyang Li, PhD

CONTACT

[email protected]

+86 0451-86412296

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Clinical Application on the R&D Purpose of Wearable Ultrasound Sensors:A Single-Center Prospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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