Blood Circulation Disorder, Deep Vein Thrombosis
Conditions
Brief summary
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
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.
Interventions
DEVICEBlood circulation device
Blood circulation device of CGM MB-1701 (Ceragem Master V6)
Sponsors
Ceragem Clinical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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. 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 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
1. Subjects who complain of a decrease in the sensation of the lower extremities or who is unable to feel the sensation of pain 2. Subjects who have inflammation or trauma on the skin that directly touches the device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Systolic Velocity (PSV) change | While 2 consecutive application (36 minutes) per one subject | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antero-posterior (AP) diameter | While 2 consecutive application (36 minutes) per one subject | 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. |
| Cross Sectional Area | While 2 consecutive application (36 minutes) per one subject | Evaluate the maximum CSA area change of the femoral vein when applied compare to before the device is applied using ultrasonic at Visti 1. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORYong Soon Yoon, MD
Presbyterian medical center
Outcome results
None listed