Post Market Study - "European Observational Study of the Sapheon™ Closure System for the Definitive Treatment of Incompetent Great Saphenous Veins: A Prospective Single Arm Multicenter Clinical Observational Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 13
- 主要终点
- Comparative Duplex Ultrasound
研究概览
简要总结
The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
详细描述
This is a post market, observational study of closure of the great saphenous vein "GSV". Efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System are consistent with or better than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. Additional comparison points may include measurements of pain and/or length of time to return to work.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤ 70 years of age.
- •Symptomatic primary Great Saphenous Vein "GSV" incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
- •CEAP classification of C2, C3 or C
- •Ability to walk unassisted.
- •Ability to attend follow-up visits.
- •Ability to understand the requirements of the study and to provide written informed consent.
- •"GSV" on standing pre-procedure Doppler Ultrasound ≥3mm and ≤10mm (maximum diameter).
排除标准
- •Life expectancy < 1 year.
- •Regular pain medication.
- •Anticoagulation including Heparin or Coumadin.
- •Previous Deep Vein Thrombosis "DVT".
- •Previous superficial thrombophlebitis in "GSV".
- •Previous venous treatment on target limb.
- •Known Hyper-coagulable disorder.
- •Conditions which prevent routine vein treatment like:
- •Acute disease,
- •Immobilization or inability to ambulate, and
- •Pregnancy.
- •Tortuous "GSV", which in the opinion of the Investigator will limit catheter placement. (no 2 primary access sites allowed).
- •Incompetent ipsilateral small saphenous or anterior accessory great saphenous vein.
- •Known sensitivity to the cyanoacrylate "CA" adhesive.
- •Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
结局指标
主要结局
Comparative Duplex Ultrasound
时间窗: Immediately Post-procedure
The Primary endpoint is a change in duplex ultrasound immediately post-procedure as compared to the pre-procedure duplex ultrasound, proving great saphenous vein closure with lack of pathological reflux.
次要结局
- Safety(Immediately post-op through 6 month Follow-up "FU")