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

Singapore General Hospital30 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Varicose Veins Venous Reflux Chronic Venous Insufficiency

Interventions

QuestionnairesOTHER

Questionnaires to access the quality of life (EQ5D, VCSS, CVVQ, CIVIQ, Patient satisfaction survey)

Eligibility

Sex: ALLMin age: 21 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \> 21 years old and ability to understand the requirements of the study and to provide informed consent 2. C2-C6 varicose veins/CVI (CEAP Class 1 patients will be excluded) 3. 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 4. Patients who had GSV, SSV or AASV diameters of 3mm to 12mm in the standing position Exclusion Criteria: 1. Current DVT or history of DVT 2. Pregnant patients 3. Arterial disease (ABPI\<0.8) 4. Sepsis 5. Patient who are unwilling to participate 6. Inability or unwillingness to complete the time-point questionnaires 7. Adverse reaction to sclerosant or cyanoacrylate previously 8. Multiple drug allergies 9. Previous intervention with the VenaSeal cyanoacrylate glue closure system 10. Severely tortuous GSV, SSV or AASV 11. Life expectancy \< 1 year 12. Active treatment for malignancy other than non-melanoma skin cancer 13. Current, regular use of systemic anticoagulation (e.g., warfarin, heparin) 14. Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease

Locations (1)

Singapre General Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Occlusion of treated vein post-procedure

Time frame: 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.

Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure

Clinical Change using Venous Clinical Severity Score (VCSS)

Data from ClinicalTrials.gov

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