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.
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.
Study Type
OBSERVATIONAL
Enrollment
15
Questionnaires to assess quality of life
Singapre General Hospital
Singapore, Singapore
Technical success at time of procedure
Occlusion of treated vein post-procedure
Time frame: Immediately post-op
Change in anatomy of treated vessel
Anatomical success as measured at each time-point using ultrasound to ensure occlusion of treated vein.
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Quality of life score using EQ-5D questionnaire
EQ5D is used to assess quality of life based on Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime.
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
CIVIQ is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging for 0 to 100 - the higher the value, the poorer the quality of life.
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)
To measure health status of varicose veins patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Clinical Change using Venous Clinical Severity Score (VCSS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Pain Score
Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)
Time frame: First 10 days post-procedure
Time taken to return to work and normal activities
Time frame: 10 days post-operation
Occlusion rates
Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Patient satisfaction with treatment
A short survey to assess patient satisfaction and if there is any observed improvement in terms of appearance and symptoms post-procedure.
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure