Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System With Cardinal Health Element Compression Sleeves
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Blood Velocity
研究概览
简要总结
This study is being conducted to evaluate the hemodynamic performance (i.e. flow of blood) in the legs using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves.
详细描述
This study is being conducted to evaluate hemodynamic performance using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves. The study is intended to confirm the system's ability to increase venous blood flow over baseline as measured by blood velocity, time average mean velocity and total volume flow, in both the femoral and popliteal veins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be ≥18 years and ≤ 89 years of age.
- •Subject must be able to speak and read English.
- •Subject must have both legs fully intact (cannot be an amputee) with normal function.
- •Subject must be able to commit to the full study duration (approximately 1-2 hours of uninterrupted time).
- •Subject legs must fit into the provided knee length compression sleeves (<32").
- •Subject must give written informed consent.
排除标准
- •Subject is currently pregnant or breastfeeding.
- •Subject has a positive COVID history within the previous 6 months.
- •Subject presents with
- •- local leg condition with which the sleeves would interfere such as dermatitis, vein ligation (immediate post-operative), gangrene, recent skin graft, or any other open wound
- •- arteriosclerosis or other ischemic vascular diseases as indicated by absence of pedal pulses and/or history of intermittent claudication with positive pain response
- •- edema of legs or pulmonary edema from congestive heart failure
- •- deformity of the leg
- •- current Deep Vein Thrombosis as identified during baseline clinical screening
- •- recent or old Deep Vein Thrombosis as identified during baseline clinical screening
- •- reflux in the superficial or deep veins
- •- history of DVT/PE
- •- known May-Thurner Syndrome
- •Subject who, in the opinion of the investigator, is not an appropriate candidate for the study
结局指标
主要结局
Blood Velocity
时间窗: baseline, +10 minutes
Blood Velocity (Baseline, Peak) will be assessed via ultrasound in the popliteal and femoral veins.
Time Average Mean Velocity
时间窗: baseline, +10 minutes
Time Average Mean Velocity (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins.
次要结局
- Total Volume Flow(baseline, +10 minutes)