Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Ecchymosis
研究概览
简要总结
The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.
详细描述
Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must provide written informed consent.
- •Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser.
排除标准
- •Subjects who require additional treatments in either leg within 30 days before or after the study procedure.
- •Subjects who are participating in another investigational study.
研究组 & 干预措施
Seg. RF Ablation & ClosureFAST catheter
Seg. RF Ablation & ClosureFAST catheter
干预措施: Seg. RF Ablation & ClosureFAST catheter (Device)
Endovenous Laser
Treatment invention of venous disease with an Endovenous Laser.
干预措施: Endovenous Laser (Device)
结局指标
主要结局
Ecchymosis
时间窗: 1 Month post treatment (no baseline)
0-5 scale (5 most severe) 0: None 1. \<25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below tx segment
Pain
时间窗: 1 Month
Pain 0-10 scale (10 most severe)
Complications
时间窗: 1 month
Sequelae at any follow-up
Tenderness
时间窗: 1 Month
Tenderness 0-10 scale (10 most severe)
Tenderness
时间窗: 2 Weeks
Tenderness 0-10 scale (10 most severe)
Pain
时间窗: 48 Hour
Pain 0-10 scale (10 most severe)
Pain
时间窗: 1 Week
Pain 0-10 scale (10 most severe)
Pain
时间窗: 2 Weeks
Pain 0-10 scale (10 most severe)
Tenderness
时间窗: 48 Hour
Tenderness 0-10 scale (10 most severe)
Tenderness
时间窗: 1 Week
Tenderness 0-10 scale (10 most severe)
Ecchymosis
时间窗: 48 Hours post treatment (no baseline)
0-5 scale (5 most severe) 0: None 1. \<25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below treated (tx) segment
Ecchymosis
时间窗: 1 Week post treatment (no baseline)
0-5 scale (5 most severe) 0: None 1. \<25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below tx segment
Ecchymosis
时间窗: 2 Weeks post treatment (no baseline)
0-5 scale (5 most severe) 0: None 1. \<25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below tx segment
次要结局
- Change in CIVIQ QOL(1 Month)
- VCSS(1 Month)
- VCSS(48 Hours)
- VCSS(1 Week)
- VCSS(2 Weeks)
- Change in CIVIQ QOL(48 Hours)
- Change in CIVIQ QOL(1 Week)
- Change in CIVIQ QOL(2 Week)