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
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
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.
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.
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: