Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore

Study Overview
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Brief Summary
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To assess the efficacy of the Venablock©Vein Sealing System (VBVS) for the treatment of lower extremity superficial truncal veins in a real-world clinical setting in a multi-racial Asian population in Singapore.

Detailed Description
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The purpose of the Registry to Investigate the Efficacy and Safety of Venablock©Vein Sealing System for Varicose Veins in Singapore (RIVERIA), is to investigate the performance of cyanoacrylate glue closure (CAC) using this device, in which multiple incompetent superficial saphenous truncal veins (great saphenous (GSV), short saphenous vein (SSV), anterior accessory saphenous vein (AASV) will be treated at the same setting, and compression stockings will not be used post-operatively. The inclusion criteria for this study will be liberalized, and veins up to 12mm in diameter will be treated. As such,RIVIERA will be the first prospective trial conducted in Asia on a predominantly Asian cohort of patients to report on the performance of Venablock© for blocking incompetent truncal veins. This study specifically focuses on the initial technical outcomes, safety, anatomical occlusion, and patient experience after treatment with Venablock© with broader inclusion of patients than previous caucasian based trials.

Official Title
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Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore

Conditions
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Varicose Veins, Venous Reflux, Chronic Venous Insufficiency

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 21 years old and ability to understand the requirements of the study and to provide informed consent C2-C6 varicose veins/CVI (CEAP Class 1 patients will be excluded) 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 had GSV, SSV or AASV diameters of 3mm to 12mm in the standing position Exclusion Criteria: Current DVT or history of DVT Pregnant patients Arterial disease (ABPI<0.8) Sepsis Patient who are unwilling to participate Inability or unwillingness to complete the time-point questionnaires Adverse reaction to sclerosant or cyanoacrylate previously Multiple drug allergies Previous intervention with the VenaSeal cyanoacrylate glue closure system Severely tortuous GSV, SSV or AASV 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
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Venablock<br>Patients that have undergone Venablock treatment | Other: Questionnaires<br>* Questionnaires to access the quality of life (EQ5D, VCSS, CVVQ, CIVIQ, Patient satisfaction survey)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion of treated vein post-procedure |  | Immediately post-op | 
| Change in anatomy of treated vessel | Anatomical Success as measured at each timepoint using ultrasound to ensure occlusion of treated vessel. Recurrence or treatment failure will be defined as a re-opening of a segment > 5cm in length. | 2 weeks, 3 months, 6 months, 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Score using the 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. The higher the score, the better the quality of life is. | 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 |  | Recorded 10 days post-procedure | 
| 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: survey | A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure. Options range from highly unsatisfied to highly satisfied. | 2 weeks, 3 months, 6 months, 12 months post-procedure | 
| Cost effectiveness of the intervention | to evaluate the cost involved with the procedure performed | 12 months post-procedure | 

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