Wearable ultrasound sensors for early diagnosis and real-time monitoring
Official title: Clinical Application on the R&D Purpose of Wearable Ultrasound Sensors:A Single-Center Prospective Study
Run by Chinese PLA General Hospital · NCT07009873 · Data updated 2026-11-12
This project will try a wearable ultrasound sensor to detect and monitor blood clots, heart-failure changes, and continuous bedside issues in ICU patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 15, 2025 |
| Main results expected | April 15, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT07009873 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults (≥18) with a relevant diagnosis—clinically stable HFrEF/HFpEF on standard therapy, imaging-confirmed lower-limb DVT (anticoagulated or scheduled for intervention), or ICU/post-op patients who need continuous bedside ultrasound—and who have an adequate acoustic window and intact skin at the sensor site.
✕Probably not a fit
Patients unlikely to benefit include those with poor acoustic windows, local skin infection or implants at the sensor site, inability to cooperate, or arm-specific exclusions such as recent acute MI/uncontrolled arrhythmia (heart-failure arm), active bleeding or severe coagulopathy (DVT arm), or unstable multi-organ failure (ICU arm).
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational effort tests a novel wearable ultrasound imaging sensor intended for early diagnosis and continuous monitoring of conditions such as lower-limb DVT, heart failure, and ICU/postoperative needs. Adults with imaging-confirmed DVT, clinically stable HFrEF or HFpEF on standard therapy, or ICU/post-op patients requiring continuous bedside ultrasound are eligible if they have an adequate acoustic window and intact skin at the sensor site. The device will collect repeated or continuous ultrasound data and its image quality and diagnostic performance will be compared to standard clinical ultrasound/POCUS to establish non-inferiority. Safety exclusions include poor acoustic windows, local skin infection or implants at the sensor site, inability to cooperate, and arm-specific instability or bleeding risks.
Why it matters
Potential benefit: If successful, the wearable ultrasound could enable earlier detection and continuous bedside monitoring, reducing missed events and the need for repeated conventional scans.
How similar studies have gone: Early pilot and feasibility studies of wearable and portable ultrasound devices have shown promising image acquisition and monitoring potential, but larger clinical validation is still limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Chinese PLA General Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Yukun Luo, Professor, M.D. — Chinese PLA General Hospital
- Study coordinator: Yuyang Li, PhD
- Email: 248597504@qq.com
- Phone: +86 0451-86412296
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.