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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
59
Blood circulation device of CGM MB-1701 (Ceragem Master V6)
Presbyterian Medical Center
Jeonju, South Korea
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
Time frame: While 2 consecutive application (36 minutes) per one subject
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.
Time frame: 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.
Time frame: While 2 consecutive application (36 minutes) per one subject
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