A Multiple Center, Clinical Trial to Evaluate the Efficacy and Safety of Blood Circulation Improvement Using an Investigational Device (Model Name CGM MB-1701) for the Risk Group of Deep Vein Thrombosis (DVT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Peak Systolic Velocity (PSV) change
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
blood circulation treatment
Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT)
干预措施: Blood circulation device (Device)
结局指标
主要结局
Peak Systolic Velocity (PSV) change
时间窗: 10 days from the baseline
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).
次要结局
- Peak Systolic Velocity (PSV) change(5 days from the baseline)
- Anteroposterior (AP) diameter(5 days (V3) and 10 days (V4) from the baseline)
- Cross Sectional Area (CSA)(5 days (V3) and 10 days (V4) from the baseline)
- Leg volume (3D scanner)(5 days (V3) and 10 days (V4) from the baseline)