Clinical Application of Wearable Ultrasound Sensors

Not yet recruiting

• Conditions: DVT - Deep Vein Thrombosis; POCUS

• Registration Number: NCT07009873
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-04-27
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Study Start: 2025-06-15
• Primary Completion: 2026-04-15
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Image Quality	Day 1 (Baseline): Measured immediately after first wearable sensor placement	* Axial Resolution; * Unit: millimeters (mm); * Lateral Resolution; * Unit: millimeters (mm)

Secondary Outcome Measures

Name	Time	Method
Consistency of image quality	Day 1 (Baseline): Measured during the initial imaging session	Diagnostic Sensitivity Unit: percent (%)

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China