Efficacy and Safety of Endovenous Microwave Ablations for Treatment of Varicose Veins in Singapore

Study Overview
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Brief Summary
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The purpose of this study is to assess change in patient's symptoms before and after Endovenous Microwave Ablation (EMA) as treatment for varicose veins. At the same time, it is to evaluate the effectiveness of EMA and its treatment outcomes over a period of 1 year.

Detailed Description
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Healthy leg veins have valves that allow blood to move in one direction from the lower leg to the heart. These valves open when blood is flowing toward the heart and then quickly close to stop any backward flow. When veins weaken, their valves cannot close properly, causing reversal of blood flow in the vein or venous reflux. Venous reflux due to the incompetent valves in the superficial venous system is the most common form of venous insufficiency, also known as varicose veins. This happens most often in the veins closest to the skin; the superficial veins. Varicose veins may or may not have associated symptoms and can look like twisted, bulging, rope-like cords or even small spider veins. While sometimes asymptomatic, varicose veins can be associated with pain, aching or cramping in the legs, heaviness or a tired sensation, paresthesia, pruritus, edema, inflammation with superficial phlebitis or thrombophlebitis, ulceration, bleeding from ulcerated varicosities, ecchymosis from subcutaneous rupture of varicosities, and deep venous thrombosis from extension of superficial thrombophlebitis. Venous insufficiency of lower extremities is a very common condition that is influenced by genetic and mechanical factors, and is a chronic and progressive disorder. Prevalence estimates vary widely by geographic location, with the highest reported rates in Western countries, including Western Europe and the United States. Prevalence estimates of varicose veins range from <1% to up to 73% in females and 2% to up to 56% in males. The reported prevalence ranges presumably reflect differences in the population distribution of risk factors, accuracy in application of diagnostic criteria, and the quality and availability of medical diagnostic and treatment resources. Risk factors for venous insufficiency include older age, female gender and pregnancy, family history of venous disease, obesity and occupations associated with prolonged standing. There are a number of treatment options available to subjects with varicose veins, including vein stripping surgery, and thermal ablation; for example, Endovenous laser ablation (EVLA), radiofrequency ablation (RFA), and sclerotherapy. Recent technological advances have also brought about new treatment methods that are non-thermal, non-tumescent (NTNT). These include Venaseal and Clarivein. The goal of each of these treatment regimens is to eliminate source of reflux in order to control the progression of the disease, improve symptoms, promote ulcer healing, and prevent recurrence or a combination of these. The latest treatment available uses microwave ablation, which is a sub-type of radiofrequency and has the same characteristics as radiofrequency ablation. The aim of this study is to report a collaborative, prospective Singaporean experience using the ECO Varicose Veins Therapeutic Unit from ECO (Nanjing ECO Microwave System Co., Ltd) for Endovenous Microwave Ablation (EMA) to treat primary great and short saphenous vein reflux and to evaluate its safety, efficacy and performance.

Official Title
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Pilot Study to Investigate the Efficacy and Safety of Endovenous Microwave Ablations for Treatment of Varicose Veins in Singapore

Conditions
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Venous Insufficiency, Varicose Veins, Vascular Diseases

Intervention / Treatment
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* Other: Questionnaires
* Other: Physical examinations


Participation Criteria
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Eligibility Criteria
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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 AASV diameters of 3mm to 12mm in the standing postition. 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 us of narcotic analgesia or NSAIDS to control pain associated with venous disease

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Endovenous Microwave Ablations<br>Patients that have undergone Endovenous Microwave Ablation from ECO (Nanjing ECO Microwave System Co., Ltd) to treat primary great and short saphenous vein reflux | Other: Questionnaires<br>* Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)<br>Other: Physical examinations<br>* GSV/SSV/AASV reflux, CEAP Classification (Clinical, Aetiological, Anatomical and Pathophysiology), Venous Clinical Severity Score (VCSS) and duplex ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success at time of procedure | Occlusion of treated vein post-procedure | Immediately post-procedure | 
| Anatomical Success | Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound | 2 weeks to 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life score using EQ-5D questionnaire | EQ-5D 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 | Baseline, 2-weeks, 3 months, 6 months and 12 months | 
| Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) | CIVIQ-14 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 from 0 to 100 - the higher the value, the poorer the quality of life. | Baseline, 2-weeks, 3 months, 6 months and 12 months | 
| Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ) | To measure health status of varicose vein 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 | Baseline, 2-weeks, 3 months, 6 months and 12 months | 
| 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). | Baseline, 2-weeks, 3 months, 6 months and 12 months | 
| Time taken to return to work and normal activities | Patient will be given a diary to record the day when they return to work and normal activities. | 10 days post-op | 
| Patient's satisfaction | To rate satisfaction with overall teatment regime with a numerical scale of 0 (least satisfied) to 10 (most satisfied) | 2-weeks, 3 months, 6 months and 12 months | 
| Pain score post-procedure | Participants will record their pain score using the Visual Analogue Score (VAS) for pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). | 10 days post-op | 
| Occulsion rates | Duplex ultrasound performed at specific timepoints to ensure that the treated vein is occluded. | 2-weeks, 3 months, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endovenous microwave ablation