Clinical Application of Wearable Ultrasound Sensors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Heart-failure arm: Clinically stable HFrEF or HFpEF on standard therapy
Disqualifiers
Poor acoustic window preventing interpretable images
Local skin infection, open wound, or implant/hardware blocking sensor
Inability to cooperate with monitoring
Heart-failure arm: Acute MI or uncontrolled arrhythmia in past 3 months
Trial population
Participant recruitment will be conducted by licensed physicians during routine clinical follow-up.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.
Other interventionThis study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 placement2
Image Quality
* Axial Resolution * Unit: millimeters (mm) * Lateral Resolution * Unit: millimeters (mm)
Time frame
Day 1 (Baseline): Measured immediately after first wearable sensor placementSecondary outcomes
1
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 placement2
Consistency of image quality
Intra-session Reproducibility of SNR Unit: Intraclass correlation coefficient (ICC)
Time frame
Day 1 (Baseline): Measured during the initial imaging session3
Consistency of image quality
Diagnostic Sensitivity Unit: percent (%)
Time frame
Day 1 (Baseline): Measured during the initial imaging sessionSponsors and contacts
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Source ClinicalTrials.gov