An interventional study of Questionnaires and Physical examinations in Venous Insufficiency, Varicose Veins and Vascular Diseases, sponsored by Singapore General Hospital. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-09-27.
Sponsored by Singapore General Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.
This study's enrollment of 30 is below the median of 78 across 639 interventional studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
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 · Other: Physical examinations
Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)
GSV/SSV/AASV reflux, CEAP Classification (Clinical, Aetiological, Anatomical and Pathophysiology), Venous Clinical Severity Score (VCSS) and duplex ultrasound
Technical Success at time of procedure
Occlusion of treated vein post-procedure
Time frame: Immediately post-procedure
Anatomical Success
Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound
Time frame: 2 weeks to 12 months post-procedure
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
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 10 days post-op
Occulsion rates
Duplex ultrasound performed at specific timepoints to ensure that the treated vein is occluded.
Time frame: 2-weeks, 3 months, 6 months and 12 months
Plan to share: No
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Singapore General Hospital