CEFID-I (CEra Flow Improves DVT-1)

Study Overview
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Brief Summary
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The study is a single center clinical trial to evaluate the efficacy and safety of blood circulation improvement using an investigational medical device, which is a product on the market and it's name is Ceragem Master V6, for the risk group of Deep Vein Thrombosis (DVT) and the ordinary person. The study compares before and after the application by one time application.

Detailed Description
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The efficacy and safety evaluation are conducted before and after (or during) the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day.

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

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 for all subjects; 1. Adult men and women over 19 years of age 2. 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. Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea D-dimer negative test result (Even if the D-dimer test is positive, the subject can be selected through the additional test at the discretion of investigator.) 3. Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent Additional Inclusion Critetia for the DVT risk subjects; 1. Subjects have two or more points of venous thromboembolism (hereinafter referred to as VTE) clinical prediction score (Two-level wells scroe) at the time of screening Exclusion Criteria: Subjects who complain of a decrease in the sensation of the lower extremities or who is unable to feel the sensation of pain Subjects who 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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Accepts Healthy Volunteers

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) and the ordinary person | Device: Blood circulation device<br>* Blood circulation device of CGM MB-1701 (Ceragem Master V6)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Systolic Velocity (PSV) change | Evaluate the maximum blood flow rate (PSV) change in the femoral vein when applied compared to before application of the device using ultrasonic at Visit 1 | While 2 consecutive application (36 minutes) per one subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antero-posterior (AP) diameter | Evaluate the the maximum AP diameter change of the femoral vein when applied compared to before the device is applied using ultrasonic at Visit 1. | While 2 consecutive application (36 minutes) per one subject | 
| Cross Sectional Area | Evaluate the maximum CSA area change of the femoral vein when applied compare to before the device is applied using ultrasonic at Visti 1. | While 2 consecutive application (36 minutes) per one subject |