A Crossover Study of the Hemodynamic Effect of the OsciPulse Device Compared to Reference Therapies
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- OsciFlex LLC
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Venous valve sinus rouleaux
研究概览
简要总结
This study will evaluate the effects on venous blood flow of the investigational device, OsciPulse system, which is an external intermittent limb compression device. The study will enroll healthy human subjects who will have their deep venous blood flow measured by vascular ultrasound during immobility, use of the OsciPulse system, and use of two reference vascular compression devices. Our hypothesis is that the OsciPulse system will create distinct patterns of venous flow, specifically at the site of venous valves, in comparison to the reference compression devices.
详细描述
Enrolled healthy subjects will undergo and initial vascular ultrasound imaging procedure to locate a deep venous valve in either the sapheno-femoral junction or femoral trifurcation sites. Once the imaging valve is identified the baseline level of venous flow will be collected in 30 s video clips of 2D color Doppler videos and spectral Doppler. Next, either the OsciPulse device, or one of the two reference therapy devices, will be applied by study personnel according to the device's specific instructions. The subject will wear the device during the capture of 1 spectral Doppler clip and three 30 s 2D color Doppler ultrasound clips on both the left and right leg. Next, the remaining two devices will be applied based on instructions, and vascular ultrasound clips captured for each. Completion of this visit protocol will be the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult age ≥40 years old
- •Generally healthy.
- •No history of diagnosed vascular disease including: DVT, PE, VTE, peripheral vascular disease, post-phlebitic syndrome, or chronic venous insufficiency.
- •Mentally alert and understand English proficiently.
- •Able to give informed consent.
排除标准
- •Skin breaks, abrasion, or irritation in the area of the limb in contact with the OsciPulse device or reference therapies.
- •Severe peripheral artery or venous disease.
结局指标
主要结局
Venous valve sinus rouleaux
时间窗: Visit 1 - 60 minutes
The degree of red blood cell rouleaux in the sinus of venous valves will be measured using B-mode ultrasound.
Venous valve sinus forward flow volume index
时间窗: Visit 1 - 60 minutes
The volume flow index (mL/mL) will be measured for flow in the valve sinus region that is moving back towards the heart (forward flow). The venous flow at a valve will be measured using 2D color Doppler ultrasound, and flow volume index calculated from the resulting video clips.
Venous valve sinus reversing flow volume index
时间窗: Visit 1 - 60 minutes
The volume flow index (mL/mL) will be measured for flow in the valve sinus region that is moving away from the heart (reversing flow). The venous flow at a valve will be measured using 2D color Doppler ultrasound, and flow volume index calculated from the resulting video clips.
Deep vein centerline flow
时间窗: Visit 1 - 60 minutes
The velocity of venous flow measured by spectral Doppler ultrasound in the deep femoral vein.
次要结局
未报告次要终点