NCT00928421已完成2 期
An Open-label, Single-dose Pilot Study to Evaluate the Efficacy and Safety of Varisolve® (Polidocanol Endovenous Microfoam) 0.125% [0.2%] for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Responders to Treatment, Assessed by Duplex Ultrasound
研究概览
简要总结
To determine the effect and safety of Varisolve® 0.125% [0.2%]
详细描述
In patients with SFJ incompetence due to reflux of the Great Saphenous Vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities: using duplex ultrasonography, to evaluate the efficacy of Varisolve® 0.125% [0.2%] as assessed by the elimination of SFJ reflux and/or occlusion of the treated vein
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female; age of consent to 75 years
- •Baseline VEINES-Sym Questionnaire score less than 75 points
- •Superficial venous disease manifested by both symptoms and visible varicosities
- •Varicose vein clinical classification CEAP 2 through 5
- •Incompetence of SFJ (reflux > 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
- •Ability to comprehend and sign an informed consent document and complete study questionnaires in English
排除标准
- •Incompetence of the small saphenous vein (SSV)
- •Ultrasonographic or other evidence of current or previous deep vein thrombosis, occlusion or incompetence
- •Leg obesity impairing the ability to access the vein to be treated and/or to follow the post-procedural compression recommendations.
- •Peripheral arterial disease in the leg to be treated contraindicating post-procedural compression.
- •Reduced mobility (inability to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day).
- •Planned prolonged automobile, bus, or air travel within 4 weeks following treatment, unless the patient can walk for at least 5 consecutive minutes every hour during travel.
- •History of pulmonary embolism or stroke.
- •Major surgery, prolonged hospitalization or pregnancy within 3 months of screening.
- •Current anticoagulation therapy (within 7 days of enrollment).
- •Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening.
- •Previous treatment in this study or in a previous Varisolve® study.
- •Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.) or clinically significant laboratory abnormalities.
- •Known allergic response to polidocanol, or severe and multiple allergic reactions.
- •Women of childbearing potential not using effective contraception for at least one month prior to study enrollment and/or unwilling to continue birth control until their last study visit.
- •Pregnant or lactating women.
- •Current alcohol or drug abuse.
研究组 & 干预措施
Varisolve 0.125%
Experimental
干预措施: Polidocanol Endovenous Microfoam 0.125% (Drug)
结局指标
主要结局
Responders to Treatment, Assessed by Duplex Ultrasound
时间窗: 8 weeks
Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.
次要结局
未报告次要终点
研究者
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