Clinical Application of Wearable Ultrasound Sensors

Chinese PLA General Hospital (301 Hospital)

Status: Not yet enrolling

Conditions: POCUS; DVT - Deep Vein Thrombosis

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

Study type: Observational

Funder types: Other

Identifiers

NCT07009873

S2025-096-01

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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