High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Pilot Study to InVestigate the Efficacy and Safety of High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore (VESPA)

Conditions
-----------------
Varicose Veins, Venous Reflux, Chronic Venous Insufficiency

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Current DVT or history of DVT Recurrent varicose veins Pregnant patients Arterial disease (ABPI<0.8) Sepsis 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIFU<br>Patients that have undergone high focused ultrasound treatment for varicose veins | Other: Questionnaires<br>* Questionnaires to assess quality of life<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success at time of procedure | Occlusion of treated vein post-procedure | 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. | 2 weeks, 3 months, 6 months, 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 2 weeks, 3 months, 6 months, 12 months post-procedure | 
| Clinical Change using Venous Clinical Severity Score (VCSS) | VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe). | 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) | First 10 days post-procedure | 
| Time taken to return to work and normal activities |  | 10 days post-operation | 
| Occlusion rates | Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded | 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. | 2 weeks, 3 months, 6 months, 12 months post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endovenous Ablation