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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blood circulation treatment | Experimental | Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood circulation device | Device | Blood circulation device of CGM MB-1701 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Systolic Velocity (PSV) change | Compare the PSV change in the right lower extremity femoral vein at 10 days (V4) after application of the test device compared to the baseline (V2). | 10 days from the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Systolic Velocity (PSV) change | Compare the PSV change in the right lower extremity femoral vein at 5 days (V3) after application of the test device compared to the baseline (V2). | 5 days from the baseline |
| Anteroposterior (AP) diameter |
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Inclusion Criteria:
(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:
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| Name | Affiliation | Role |
|---|---|---|
| Joon-shik Yoon, MD | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presbyterian Medical Center | Jeonju | South Korea | ||||
| Korea University Guro Hospital |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Compare the maximum AP diameter change of the right lower femoral vein at 5 days (V3) and 10 days (V4) after the application of the test device compared to the baseline (V2).
| 5 days (V3) and 10 days (V4) from the baseline |
| Cross Sectional Area (CSA) | Compare the maximum CSA change of the right lower femoral vein at 5 days (V3) and 10 days (V4) after the application of the test device compare to the baseline (V2). | 5 days (V3) and 10 days (V4) from the baseline |
| Leg volume (3D scanner) | Compare the amount of change in leg volume (3D scanner) (left and right) after application at 5 days (V3) and 10 days (V4) compared to the baseline (V2). | 5 days (V3) and 10 days (V4) from the baseline |
| Seoul |
| South Korea |
| Seoul National University Bundang Hospital | Seoul | South Korea |