Safety and Feasibility of the ElastiMed's SACS - Smart Active Compression Stocking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Device feasibility measured by an increase in blood flow velocity
研究概览
简要总结
The main objective of this study is to demonstrate the safety and the feasibility of this device, and its ability to increase venous blood flow
Primary safety Endpoint:
To demonstrate the safety of the device- no serious adverse effect
Primary feasibility Endpoint:
Increase the blood flow velocity
The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein and the femoral vein.
The volunteers will rest at controlled environment room . Measurements will be performed after 30 min of rest without the device on the leg (baseline) and after 30 min of device activity .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18<x<70 Years
- •Written informed consent has been sign by subject
- •With two healthy limbs - Normal blood flow according to leg deep vein Duplex test
排除标准
- •Positive pregnancy test
- •Breastfeeding woman
- •BMI 18.5 > X or X>25
- •Suffering from edema
- •Atrial fibrillation
- •Ulcers or cellulitis in regions covered by the compression device
- •Active phlebitis
- •Muscular disorders, or compartment syndrome
- •Heavy smoker >10 cigarettes a day
- •Subjects with altered mental status/inability to provide informed consent
- •Hematological disorders
研究组 & 干预措施
ElastiMed's SACS
Healthy Subjects which the Elastimed's SACS will be tried on
干预措施: ElastiMed's SACS (Device)
结局指标
主要结局
Device feasibility measured by an increase in blood flow velocity
时间窗: 60 min
The primary feasibility assessment will be based on the ability of the device to increase the blood flow velocity at the popliteal vein. The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein. Two Measurements will be performed, the first will be after 30 minutes of rest without the device on the leg (baseline) (T0) and the second will be after 30 min of device activity
Safety measured by the number of subjects with serious adverse events
时间窗: 60 min
The safety analysis set will contain of all subjects who were enrolled into the study. Individual listings of adverse events including type of device, adverse events (reported term), seriousness, duration, relationship to the study device, severity and the adverse events outcome will be provided
次要结局
未报告次要终点