Efficacy and Safety of Endovenous Microwave Ablations for Treatment of Varicose Veins in Singapore (MAESTRO)
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|ClinicalTrials.gov Identifier: NCT04524793|
Recruitment Status : Active, not recruiting
First Posted : August 24, 2020
Last Update Posted : September 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Venous Insufficiency Varicose Veins Vascular Diseases||Other: Questionnaires Other: Physical examinations||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Investigate the Efficacy and Safety of Endovenous Microwave Ablations for Treatment of Varicose Veins in Singapore|
|Actual Study Start Date :||May 9, 2020|
|Actual Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 2021|
Endovenous Microwave Ablations
Patients that have undergone Endovenous Microwave Ablation from ECO (Nanjing ECO Microwave System Co., Ltd) to treat primary great and short saphenous vein reflux
Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)
Other: Physical examinations
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 [ Time Frame: Immediately post-procedure ]Occlusion of treated vein post-procedure
- Anatomical Success [ Time Frame: 2 weeks to 12 months post-procedure ]Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound
- Quality of Life score using EQ-5D questionnaire [ Time Frame: Baseline, 2-weeks, 3 months, 6 months and 12 months ]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
- Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) [ Time Frame: Baseline, 2-weeks, 3 months, 6 months and 12 months ]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.
- Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ) [ Time Frame: Baseline, 2-weeks, 3 months, 6 months and 12 months ]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
- Clinical Change using Venous Clinical Severity Score (VCSS) [ Time Frame: Baseline, 2-weeks, 3 months, 6 months and 12 months ]VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (Mild) , 2(Moderate), 3 (Severe).
- Time taken to return to work and normal activities [ Time Frame: 10 days post-op ]Patient will be given a diary to record the day when they return to work and normal activities.
- Patient's satisfaction [ Time Frame: 2-weeks, 3 months, 6 months and 12 months ]To rate satisfaction with overall teatment regime with a numerical scale of 0 (least satisfied) to 10 (most satisfied)
- Pain score post-procedure [ Time Frame: 10 days post-op ]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).
- Occulsion rates [ Time Frame: 2-weeks, 3 months, 6 months and 12 months ]Duplex ultrasound performed at specific timepoints to ensure that the treated vein is occluded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524793
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Tang Tjun Yip||Singapore General Hospital|