CEFID-II (CEra Flow Improves DVT-II)

Study Overview
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Brief Summary
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For Deep Vein Thrombosis (DVT) risk groups, the effect and safety of blood circulation improvement before and after application are evaluated using an investigational device (model name CGM MB-1701).

Detailed Description
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The investigator applies the test device to the appropriate subjects for a total of 10 days (+1 days) at the institution and nursing hospital, and upon discharge for long-term follow-up investigation, the investigational device is applied at subjects' home according to the subject's consent for about 3 months.

Official Title
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A Multiple Center, Clinical Trial to Evaluate the Efficacy and Safety of Blood Circulation Improvement Using an Investigational Device (Model Name CGM MB-1701) for the Risk Group of Deep Vein Thrombosis (DVT)

Conditions
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Blood Circulation Disorder, Deep Vein Thrombosis

Intervention / Treatment
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* Device: Blood circulation device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women over 19 years of age Subjects who have not been diagnosed with deep vein thrombosis in the lower extremities through the following test results prior to the application of medical devices. (1) Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea (2) D-dimer negative test result (Even if D-dimer is tested positive, it can be selected through additional tests at the discretion of investigator.) 3. Subjects have 2 or more points of venous thromboembolism (hereinafter referred to as VTE) clinical prediction score (Two-level wells score) at the time of screening. 4. Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent Exclusion Criteria: Subjects complain of a decrease in the sensation of the lower extremities or is unable to feel the sensation of pain Subjects have inflammation or trauma on the skin that directly touches the device

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blood circulation treatment<br>Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT) | Device: Blood circulation device<br>* Blood circulation device of CGM MB-1701<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Systolic Velocity (PSV) change | Compare the PSV change in the right lower extremity femoral vein at 10 days (V4) after application of the test device compared to the baseline (V2). | 10 days from the baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Systolic Velocity (PSV) change | Compare the PSV change in the right lower extremity femoral vein at 5 days (V3) after application of the test device compared to the baseline (V2). | 5 days from the baseline | 
| Anteroposterior (AP) diameter | Compare the maximum AP diameter change of the right lower femoral vein at 5 days (V3) and 10 days (V4) after the application of the test device compared to the baseline (V2). | 5 days (V3) and 10 days (V4) from the baseline | 
| Cross Sectional Area (CSA) | Compare the maximum CSA change of the right lower femoral vein at 5 days (V3) and 10 days (V4) after the application of the test device compare to the baseline (V2). | 5 days (V3) and 10 days (V4) from the baseline | 
| Leg volume (3D scanner) | Compare the amount of change in leg volume (3D scanner) (left and right) after application at 5 days (V3) and 10 days (V4) compared to the baseline (V2). | 5 days (V3) and 10 days (V4) from the baseline |