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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality |
| Day 1 (Baseline): Measured immediately after first wearable sensor placement |
| Image Quality |
| Day 1 (Baseline): Measured immediately after first wearable sensor placement |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency of image quality | Image Clarity Score Unit: 5-point Likert scale (1 = poor to 5 = excellent) | Day 1 (Baseline): Measured immediately after first wearable sensor placement |
| Consistency of image quality |
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Inclusion Criteria:
Arm-specific:
Exclusion Criteria:
Arm-specific:
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Participant recruitment will be conducted by licensed physicians during routine clinical follow-up.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuyang Li, PhD | Contact | +86 0451-86412296 | 248597504@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yukun Luo, Professor, M.D. | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Intra-session Reproducibility of SNR Unit: Intraclass correlation coefficient (ICC)
| Day 1 (Baseline): Measured during the initial imaging session |
| Consistency of image quality | Diagnostic Sensitivity Unit: percent (%) | Day 1 (Baseline): Measured during the initial imaging session |