NCT05193643已完成不适用
Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Single Center Prospective Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Technical Feasibility
研究概览
简要总结
This is a one-arm, open label, prospective, single-center study. Primary objective To evaluate the feasibility of HIFU for treatment of Great Saphenous Vein using assessments of patient experience and response to treatment.
Secondary objective To assess the general safety and ablation rate outcomes following HIFU treatment of GSV
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate for venous procedure with primary GSV insufficiency involving reflux in the segment to be treated
- •CEAP-clinical classification ≥ 2
- •Physical condition allowing ambulation after the procedure.
- •Agree to comply with the Clinical investigation plan and follow-up schedule of the study
- •Targeted tissue reachable for treatment with the device - meaning between 5mm and 24mm below the skin surface.
- •Age over 22 years at the time of enrollment.
- •No acute venous thrombosis.
- •No complete or near complete deep vein post-thrombotic disease.
- •Patient has signed and understood the written informed consent.
- •Exclusion criteria
- •Patient is pregnant
- •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 or device.
- •Ankle-brachial index <7 (ABI)
- •Undergoing active anticoagulant therapy within the last 6 months
- •Diameter of the treated anatomical segment below ≤ 2mm
排除标准
- 未提供
结局指标
主要结局
Technical Feasibility
时间窗: 3 months
Technical feasibility of the procedure in terms of the procedure technical success rate
次要结局
- Ablation of venous reflux(3 months)
研究者
研究点 (2)
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