Safety and Primary Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI) Sequel - A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The safety of using the ESVV for CVI treatment
研究概览
简要总结
The External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way venous valve and a sensor that identifies the movement of the calf muscles pump. The external device is located above the failed deep vein and exerts synchronized intermittent regulated pressure on it. Alteration in the vein structure is occurred and the blood flows in the cephalad direction, preventing the return toward the feet. The device is synchronized with the calf muscles pump to function as a one-way venous valve. This study was design in order to assess safety and efficacy of using the ESVV for treatment of consequences of deep chronic venous insufficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females age 18 and up.
- •Patient is diagnosed to have deep chronic venous insufficiency (CVI) proved by recent duplex examination.
- •Patient able to comprehend and give informed consent for participation in this study.
- •Patient must commit to both screening and treatment visits.
- •Patient must sign the Informed Consent Form.
排除标准
- •Acute deep vein thrombosis.
- •Chronic deep vein obstruction.
- •Peripheral arterial occlusive disease.
- •Ankle edema that is not caused by chronic venous insufficiency
- •Partial or complete immobility.
- •Pregnancy.
- •Known cognitive disorder.
- •Drug abuse.
- •Patient objects to the study protocol.
- •Concurrent participation in any other clinical study.
结局指标
主要结局
The safety of using the ESVV for CVI treatment
时间窗: 6 hours
Adverse events will be documented
次要结局
- Assessing the efficacy of using the ESVV for treatment of consequences of CVI.(6 hours)