Pilot Study to InVestigate the Efficacy and Safety of High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore (VESPA)
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in anatomy of treated vessel
研究概览
简要总结
The aim of the study is to evaluate the efficacy of non-invasive echotherapy for the treatment of varicose veins, within local population, using the Sonovein® device. The quality of life scores at baseline, 2 weeks, 3 months, 6 months and 12 months will be assessed using the EQ-50D, AVVQ and CIVIQ scores. Patient satisfaction at these time points will also be assessed.
详细描述
Sonovein® is a unique echotherapy solution, combining therapeutic ultrasound and ultrasound for monitoring. The high-intensity ultrasound beam is focused on the vein through a magnifying glass. As thermal energy is delivered, the thermocoagulation property of ultrasound energy affects the vein wall, causing shrinking and collapsing of the target vein. Thus creating a fibrotic seal and occluding the vessel. The treated vein is immediately closed after the procedure, and its diameter will continuously reduce over time, becoming a fibrotic chord. The treatment along the vein is steered automatically via a touch screen monitor. In-beam linear ultrasound probe allows visualisation of the vein in real-time and insures optimal accuracy. The study involves prospective data collection of 30 patients that will be undergoing HIFU as choice of treatment for their varicose veins / CVI. Questionnaires will be conducted at 5 timepoints - baseline before procedure, 2 weeks, 3 months, 6 months and 12 months. Subjects will be seen at outpatient clinic post-procedure. Besides questionnaires, physical examination and duplex ultrasound scan will be conducted at 2 weeks, 3 months, 6 months and 12 months to ensure occlusion of treated vein.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >21 years, able to understand the requirements of the study and provide informed consent.
- •C2 - C5 varicose veins / CVI
- •Symptomatic primary GSV, SSV or AASV incompetence, with reflux >0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling.
- •Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.
排除标准
- •Current DVT or history of DVT
- •Recurrent varicose veins
- •Pregnant patients
- •Arterial disease (ABPI<0.8)
- •Patients who are unwilling to participate
- •Inability or unwillingness to complete questionnaires
- •Adverse reaction to sclerosant or cyanoacrylate
- •GSV, SSV or AASV severely tortuous
- •Life expectancy < 1 year
- •Active treatment for malignancy other than non-melanoma skin cancer
- •Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
- •Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease
结局指标
主要结局
Change in anatomy of treated vessel
时间窗: 2 weeks, 3 months, 6 months, 12 months post-procedure
Anatomical success as measured at each time-point using ultrasound to ensure occlusion of treated vein.
Technical success at time of procedure
时间窗: Immediately post-op
Occlusion of treated vein post-procedure
次要结局
- Time taken to return to work and normal activities(10 days post-operation)
- Quality of life score using EQ-5D questionnaire(2 weeks, 3 months, 6 months, 12 months post-procedure)
- Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)(2 weeks, 3 months, 6 months, 12 months post-procedure)
- Clinical Change using Venous Clinical Severity Score (VCSS)(2 weeks, 3 months, 6 months, 12 months post-procedure)
- Pain Score(First 10 days post-procedure)
- Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)(2 weeks, 3 months, 6 months, 12 months post-procedure)
- Occlusion rates(2 weeks, 3 months, 6 months, 12 months post-procedure)
- Patient satisfaction with treatment(2 weeks, 3 months, 6 months, 12 months post-procedure)