A Prospective, Open Label Investigation of Safety of the Solutio™ Tumescent Catheter for Endothermal Ablation of Varicose Veins
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety related to the procedure using the Solutio™ catheter.
研究概览
简要总结
The goal of this clinical investigation is to evaluate safety of the Solutio™ catheter when administering tumescent anesthesia before treatment with endothermal ablation in adults above the age of 18, who suffer from unilateral insufficiency of the great saphenous vein (GSV).
Main question(s) to answer is:
Safety evaluated through reported Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs).
Incidence of Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE), and device deficiency (DD) throughout the investigation.
All investigation participants will:
- Undergo screening, including medical history, physical examination, and vein mapping with Doppler ultrasound.
- Have their Great Saphenous Vein (GSV) treated using Seldinger technique under ultrasound guidance.
- Receive tumescent anesthesia injected from inside the vein into the perivascular tissue at selected sites along the vein, using the investigational Solutio™ catheter under ultrasound guidance.
- Undergo endothermal ablation, Endovenous Laser Ablation (EVLA), or Radiofrequency Ablation (RFA).
- Be followed up for 28 days through scheduled phone calls (Day 1, Day 14 ±2) and clinic visits (Day 7 ±1, Day 28 ±2) to assess adverse events, pain, patient comfort, and undergo physical/clinical examinations and ultrasound examinations of the treated area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Male or Female >18 years old.
- •Subject diagnosed with venous insufficiency in the Great Saphenous Vein from the groin to the proximal 1/3 of the lower leg and with a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 2 or higher.
- •Subject is scheduled for an EVLA or RFA procedure for a unilateral insufficiency of the GSV.
- •Subject accepts to be treated with endothermal ablation as a standalone method.
- •Subject accepts to be treated without any sedation.
- •Subject is willing and able to provide written informed consent.
排除标准
- •Considered as being of high risk due to comorbidity in the opinion of the investigator.
- •Subject with known and confirmed coagulation defects.
- •Subject on anticoagulant treatment.
- •Subject who simultaneously needs to be treated with other supplemental techniques such as e.g., foam sclerotherapy, ligation, and phlebectomy.
- •Subject with GSV insufficiency in the distal 2/3 of the lower leg.
- •Subject, who demands full sedation, or general anesthesia.
- •Subject with known allergy to any of the tumescent and/or anesthetizing agents that will be used (per local standard practice) during the endothermal ablation procedure.
研究组 & 干预措施
Solutio™ catheter used to administrate tumescence during endothermal ablation of varicose veins
Administration of tumescence from inside the vein to the surrounding tissue, via Solutio™ catheter during endothermal ablation of varicose veins.
干预措施: Administration of local anesthesia (Device)
结局指标
主要结局
Safety related to the procedure using the Solutio™ catheter.
时间窗: 28 days
Safety evaluated by recording the number and type of adverse device effects (ADEs) and serious adverse device effects (SADEs) related to the procedure using the Solutio™ catheter.
次要结局
- Patient experience of pain(28 days)
- Physician feedback(1 day)