Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
- Conditions
- Chronic Venous InsufficiencyVenous RefluxVaricose Veins
- Interventions
- Other: Questionnaires
- Registration Number
- NCT04339075
- Lead Sponsor
- Singapore General Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Venablock Questionnaires Patients that have undergone Venablock treatment
- Primary Outcome Measures
Name Time Method Occlusion of treated vein post-procedure Immediately post-op Change in anatomy of treated vessel 2 weeks, 3 months, 6 months, 12 months post-procedure 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.
- Secondary Outcome Measures
Name Time Method Clinical Change using Venous Clinical Severity Score (VCSS) 2 weeks, 3 months, 6 months, 12 months post-procedure 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 Recorded 10 days post-procedure Occlusion rates 2 weeks, 3 months, 6 months, 12 months post-procedure Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded
Patient satisfaction with treatment: survey 2 weeks, 3 months, 6 months, 12 months post-procedure 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.
Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) 2 weeks, 3 months, 6 months, 12 months post-procedure 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.
Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) 2 weeks, 3 months, 6 months, 12 months post-procedure 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.
Pain Score First 10 days post-procedure Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)
Cost effectiveness of the intervention 12 months post-procedure to evaluate the cost involved with the procedure performed
Quality of Life Score using the EQ-5D questionnaire 2 weeks, 3 months, 6 months, 12 months post-procedure 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.
Trial Locations
- Locations (1)
Singapre General Hospital
🇸🇬Singapore, Singapore