Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study (VEINRESET)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Theraclion
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Vein Occlusion Rate
研究概览
简要总结
This is a multi-center series assessment with a planned accrual of 70 patients with diagnosed symptomatic primary GSV insufficiency. Patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will receive treatment with Sonovein for the targeted segments of GSV. At follow-up visits at 7 days (1 to 10 days), 3 months (+/- 20 days), 6 months (+/- 25 days), and 12 months (+/- 30 days) changes in veins and flow characteristics will be evaluated by ultrasound, and patient well-being, including pain which will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 12 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment.
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.
- •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.
排除标准
- •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 & above > 20mm
- •Patients where HIFU cannot be delivered to tissues where macro calcifications induce a significant shadow in the ultrasonic image
- •Patients where EPack must be put in contact with an ulcer
- •Patients with significant thick scars on the skin over the segment to be treated
- •Security distance respected in regards of :
- •nerves & bones
- •the surrounding vessels
- •Patient who may not be considered as good candidates for treatment by the investigator outside the explicit exclusion criteria above listed
结局指标
主要结局
Vein Occlusion Rate
时间窗: 12 months
Percentage of limbs with occlusion of the treated vein (as measured by Duplex ultrasound)
次要结局
- Clinical-Etiology-Anatomy-Pathophysiology (CEAP)(12 months)
- Venous Clinical Severity Score (VCSS)(12 months)
- Complications(12 months)
- Reflux-free Rate(12 months)