Clinical Application of Wearable Ultrasound Sensors

NCT07009873 | Recruiting

• 1 other identifier: S2025-096-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

DVT - Deep Vein Thrombosis; POCUS

Outcome Measures

Primary Outcomes (2)

• Image Quality

  * Signal-to-Noise Ratio (SNR) * Unit: decibels (dB) * Contrast-to-Noise Ratio (CNR) * Unit: decibels (dB)

  Day 1 (Baseline): Measured immediately after first wearable sensor placement

• Image Quality

  * Axial Resolution * Unit: millimeters (mm) * Lateral Resolution * Unit: millimeters (mm)

  Day 1 (Baseline): Measured immediately after first wearable sensor placement

Secondary Outcomes (3)

• Consistency of image quality

  Day 1 (Baseline): Measured immediately after first wearable sensor placement

• Consistency of image quality

  Day 1 (Baseline): Measured during the initial imaging session

• Consistency of image quality

  Day 1 (Baseline): Measured during the initial imaging session

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant recruitment will be conducted by licensed physicians during routine clinical follow-up.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yukun Luo, Professor, M.D.

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuyang Li, PhD

CONTACT

+86 0451-86412296; 248597504@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: June 8, 2025
• Study Start: August 15, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)