Minimally Invasive Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using High Intensity Focused Ultrasound (HIFU): A Single Center Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Theraclion
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Reduction of venous reflux
研究概览
简要总结
This is a single-center prospective study with a planned accrual of 35 patients with diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency (including recurrence at the thigh/groin level after previous treatment). The eligible patients must present a symptomatic Leg Veins System Insufficiency diagnosis which fulfills the inclusion/exclusion criteria. All patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will return to clinic on a separate day for the HIFU treatment. Device performance parameters will be collected during the HIFU visit. At follow-up visits at 3 days, 7 days and 3 months, changes in veins and flow characteristics will be evaluated by ultrasound and physical exam, and patient well-being, including pain and anxiety, will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 3 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment. An interim Safety Report will be issued after the first 5 patients will arrive at the 7 days visit and will be provided to the Ethics Committee. A second report will be issued once the first 5 patients will complete the follow-up period of 30 days and will be also provided to the Ethics Committee.
详细描述
The Echopulse System provides High Intensity Focused Ultrasound (HIFU) ablation of soft tissue. The energy is delivered via an extra-corporeal treatment probe, which includes an imaging system. The high-energy ultrasound waves propagate through the skin and are focused on a portion of the target tissue, generating intense heat and causing local cell apoptosis and progressive tissue volume reduction over the following months in the tissue within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues.
The Echopulse System is comprised of several components, including the console, treatment arm containing the visualization and treatment unit (VTU), and computer with touchscreen user interface. In addition, the Echopulse System is intended to be used in conjunction with a disposable cooling and coupling system known as EPack.
This is a single-center prospective study with a planned accrual of 35 patients with diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency (including recurrence at the thigh/groin level after previous treatment). The eligible patients must present a symptomatic Leg Veins System Insufficiency diagnosis which fulfills the inclusion/exclusion criteria. All patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will return to clinic on a separate day for the HIFU treatment. Device performance parameters will be collected during the HIFU visit. At follow-up visits at 3 days, 7 days and 3 months, changes in veins and flow characteristics will be evaluated by ultrasound and physical exam, and patient well-being, including pain and anxiety, will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 3 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment. An interim Safety Report will be issued after the first 5 patients will arrive at the 7 days visit and will be provided to the Ethics Committee. A second report will be issued once the first 5 patients will complete the follow-up period of 30 days and will be also provided to the Ethics Committee.
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
- •Candidate for venous procedure involving lower limb superficial insufficiency, recurrence at the thigh/groin level or perforators incompetence.
- •Physical condition allowing ambulation after the procedure.
- •Availability of the patient for all the follow-up visits.
- •Targeted tissue reachable for treatment with the device- meaning between 5mm and 26mm below the skin surface.
- •Age over 18 years of age at the time of enrollment.
- •No acute venous thrombosis.
- •No complete, or near complete deep vein thrombosis.
- •Patient has signed a written informed consent.
排除标准
- •Patient is pregnant or nursing
- •Known allergic reaction to anesthetics to be used
- •Legally incapacitated or imprisoned patients
- •Patient's vein target not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
- •Patient participating in another clinical trial involving an investigational drug, device or biologic.
研究组 & 干预措施
ECHOPULSE
Arm of patient treated by HIFU
干预措施: ECHOPULSE (Device)
结局指标
主要结局
Reduction of venous reflux
时间窗: 3 months
as measured by ultrasound
次要结局
- Measurement of flow abolition(3 months)
- Emergent Adverse Events(3 months)