Market Penetration of Laser Therapy in Venous Surgery: ZOL - ZMK Center Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Duomed
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.
研究概览
简要总结
The goal of this registry is to evaluate the indication for EndoVenous Laser Ablation (EVLA) therapy. Can this be enhanced? What are the reasons for not using the laser? Therefore, this study aims to define clear indications for EVLA by registering the incentives of the participating investigators to use the laser instead of conventional corrective surgery for the treatment of varicose veins, at baseline and post-operative. Additionally, the efficacy and safety of the different varicose vein treatments will be evaluated by registering procedural characteristics, anatomic outcome (duplex ultrasound), quality of life (AVVQ) and postoperative pain (VAS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient is at least 18 years old.
- •Patient must sign and date the informed consent form prior to treatment.
- •Presence of unilateral or bilateral primary or recurrent symptomatic varicose veins (CEAP grade ≥ C2).
- •Patient has an insufficient Great Saphenous Vein (GSV), Anterior Accessory Saphenous Vein (AASV) and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence).
排除标准
- •Current deep vein thrombosis.
- •Acute superficial thrombosis.
- •Coagulopathy or bleeding disorders.
- •Contraindications to the use of general or regional anesthesia.
结局指标
主要结局
To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.
时间窗: At 6 weeks follow-up
The participating investigators will re-evaluate the chosen treatment option and document this re-evaluation in the study database in order to define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins and to investigate whether the use of EVLA can be enlarged.
次要结局
- Pain scoring using the Visual Analog Scale (VAS)(At 6 weeks follow-up)
- Anatomic success of EndoVenous Laser Ablation (EVLA)(At 6 weeks follow-up)
- Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)(At 6 months follow-up)
- Post-operative adverse events(At 6 months follow-up)
- Re-interventions(At 6 months follow-up)
- Procedural characteristics(At index-procedure)