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Recruiting NCT07009873

Clinical Application of Wearable Ultrasound Sensors

— Observational DVT - Deep Vein Thrombosis POCUS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention..
Who it may be relevant to
Registry conditions: DVT - Deep Vein Thrombosis, POCUS. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

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

Primary outcome measures

  • Image Quality [Time frame: Day 1 (Baseline): Measured immediately after first wearable sensor placement]
  • Image Quality [Time frame: Day 1 (Baseline): Measured immediately after first wearable sensor placement]
Secondary outcome measures (3)
  • Consistency of image quality [Time frame: Day 1 (Baseline): Measured immediately after first wearable sensor placement]
  • Consistency of image quality [Time frame: Day 1 (Baseline): Measured during the initial imaging session]
  • Consistency of image quality [Time frame: Day 1 (Baseline): Measured during the initial imaging session]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

China · 1 center
  • Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT07009873 · S2025-096-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗