NL-OMON54246招募中不适用
A multicenter, open-label, non-inferiority, randomized controlled trial comparing mechanochemical endovenous ablation using Flebogrif with endovenous laser ablation in the treatment of primary great saphenous vein incompetence. - REBORN study
oordwest Ziekenhuisgroep0 个研究点目标入组 310 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age 18-80 years
- •2. Unilateral symptomatic primary GSV and SFJ incompetence
- •3. GSV diameter >= 4 or <= 12 mm
- •4. GSV treatment length >= 15 cm
排除标准
- •1. Bilateral endovenous thermal/MOCA treatment of the GSV
- •2. Simultaneous ipsilateral endovenous thermal-/MOCA treatment of additional
- •3. C6 varicose veins
- •4. Previous ipsilateral GSV or AASV treatment
- •5. Superficial thrombophlebitis or deep venous thrombosis in the last 6 months
- •6. Occlusion of deep venous system
- •7. Coagulation disorders or increased risk of thromboembolism
- •8. Direct oral anticoagulants or vitamin K antagonists
- •9. Pregnancy or lactation
- •10. Immobilization
- •11. Cognitive impairment or language barrier
- •12. Allergy or contraindication to Polidocanol
- •13. Severe renal or liver insufficiency
研究者
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