DVT - Deep Vein ThrombosisNCT07009873
Clinical Application of Wearable Ultrasound Sensors
An observational study of DVT - Deep Vein Thrombosis and POCUS, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- DVT - Deep Vein Thrombosis, POCUS
- What is being tested?
- This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participant recruitment will be conducted by licensed physicians during routine clinical follow-up.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Jia Zhang, +86 13262211459, 301irb@sina.com
About this study
Official title: Clinical Application on the R&D Purpose of Wearable Ultrasound Sensors:A Single-Center Prospective Study
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
- Being tested
- This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
- Signal-to-Noise Ratio (SNR)
- Unit: decibels (dB)
- Contrast-to-Noise Ratio (CNR)
- Unit: decibels (dB)
Measured: Day 1 (Baseline): Measured immediately after first wearable sensor placement
Image Quality
- Axial Resolution
- Unit: millimeters (mm)
- Lateral Resolution
- Unit: millimeters (mm)
Measured: Day 1 (Baseline): Measured immediately after first wearable sensor placement
Secondary outcomes (3)
Consistency of image quality
Image Clarity Score Unit: 5-point Likert scale (1 = poor to 5 = excellent)
Measured: Day 1 (Baseline): Measured immediately after first wearable sensor placement
Consistency of image quality
Intra-session Reproducibility of SNR Unit: Intraclass correlation coefficient (ICC)
Measured: Day 1 (Baseline): Measured during the initial imaging session
Consistency of image quality
Diagnostic Sensitivity Unit: percent (%)
Measured: Day 1 (Baseline): Measured during the initial imaging session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start15 Aug 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DVT - Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-kun Luo, Chinese PLA General Hospital
- Investigators
- Yukun Luo, Professor, M.D., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009873
- Sponsor's protocol ID
- S2025-096-01
- Status last verified
- Aug 2025
- First submitted
- 27 Apr 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application on the R&D Purpose of Wearable Ultrasound Sensors:A Single-Center Prospective Study
- ClinicalTrials.gov ID
- NCT07009873
- Acronym / sponsor ID
- S2025-096-01
- Conditions
- DVT - Deep Vein Thrombosis, POCUS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participant recruitment will be conducted by licensed physicians during routine clinical follow-up.
Key inclusion criteria (7 listed)
- 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
- Heart-failure arm: Clinically stable HFrEF or HFpEF on standard therapy
- DVT arm: Imaging-confirmed lower-limb DVT, anticoagulated or scheduled for intervention
Key exclusion criteria (7 listed)
- Poor acoustic window preventing interpretable images
- Local skin infection, open wound, or implant/hardware blocking sensor
- Inability to cooperate with monitoring
- Heart-failure arm: Acute MI or uncontrolled arrhythmia in past 3 months
- DVT arm: Active bleeding or severe coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention. | Other | – |
Primary outcome
Image Quality
Time frame: Day 1 (Baseline): Measured immediately after first wearable sensor placement
* Signal-to-Noise Ratio (SNR) * Unit: decibels (dB) * Contrast-to-Noise Ratio (CNR) * Unit: decibels (dB)
Image Quality
Time frame: Day 1 (Baseline): Measured immediately after first wearable sensor placement
* Axial Resolution * Unit: millimeters (mm) * Lateral Resolution * Unit: millimeters (mm)
3 secondary outcomes
Consistency of image quality
Time frame: Day 1 (Baseline): Measured immediately after first wearable sensor placement
Consistency of image quality
Time frame: Day 1 (Baseline): Measured during the initial imaging session
Consistency of image quality
Time frame: Day 1 (Baseline): Measured during the initial imaging session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yukun Luo, Professor, M.D. principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DVT - Deep Vein Thrombosis and POCUS, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuyang Li, PhD (+86 0451-86412296, 248597504@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality (time frame: Day 1 (Baseline): Measured immediately after first wearable sensor placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.