Actively Recruiting

Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID07009873

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

Led by Chinese PLA General Hospital · Updated on 2026-03-20

300

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new wearable ultrasound imaging sensor designed for early diagnosis and real-time monitoring of various conditions including cardiovascular diseases and structural issues in superficial organs. This observational study focuses on assessing the sensor's image quality and consistency to determine its potential clinical applications. The study is sponsored by the Chinese PLA General Hospital and includes adult participants aged 18 to 70 years who may have conditions like heart failure, deep vein thrombosis, or require intensive care monitoring. The study involves placing the wearable ultrasound sensor on eligible participants to capture images immediately after placement and during the initial imaging session. The primary goal is to measure the quality of these images and compare their consistency without testing any therapeutic intervention. Participants are grouped based on their condition, including clinically stable heart failure patients, those with confirmed lower-limb deep vein thrombosis, and ICU or post-operative patients needing continuous bedside ultrasound. Participants will undergo ultrasound imaging sessions where image quality and consistency are assessed. The study also monitors the suitability of the sensor placement area, including skin condition and acoustic window quality. Data collected during these sessions will help researchers understand how well the wearable sensor performs in real-time clinical settings. The total study duration extends through the initial placement and imaging assessments, with follow-up as needed to monitor sensor performance and participant safety until the study ends in 2026.

CONDITIONS

Brief Title

Clinical Application of Wearable Ultrasound Sensors

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and able to give consent
  • Diagnosis relevant to study arm such as heart failure, lower-limb deep vein thrombosis, or need for ICU monitoring
  • Adequate acoustic window and intact skin at the sensor placement site
  • Heart failure arm: Clinically stable heart failure with reduced or preserved ejection fraction on standard treatment
  • DVT arm: Imaging-confirmed lower-limb deep vein thrombosis, either anticoagulated or scheduled for intervention
  • ICU arm: ICU or post-operative patients requiring continuous bedside ultrasound monitoring
Not Eligible

You will not qualify if you...

  • Poor acoustic window preventing clear images
  • Local skin infection, open wound, or implant/hardware blocking the sensor placement
  • Inability to cooperate with monitoring procedures
  • Heart failure arm: Acute myocardial infarction or uncontrolled arrhythmia in the past 3 months
  • DVT arm: Active bleeding or severe blood clotting disorder
  • ICU arm: Unstable multi-organ failure preventing safe monitoring

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo initial imaging sessions using the wearable ultrasound sensors to assess image quality and consistency.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Duration varies by participant and clinical need

Participants are observed with wearable ultrasound sensors for ongoing monitoring according to their clinical condition.

Visit schedule depends on clinical monitoring requirements

Trial Site Locations

Total: 1 location

1

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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Research Team

Y

Yuyang Li, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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