CEFID-II (CEra Flow Improves DVT-II)

Ceragem Clinical

Status

Completed

Conditions

Deep Vein Thrombosis

Blood Circulation Disorder

Treatments

Device: Blood circulation device

Study type

Interventional

Funder types

Industry

Identifiers

NCT05511064

CGM-21-031

Details and patient eligibility

About

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).

Full description

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.

Enrollment

60 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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