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

Singapore Health Services (SingHealth)

Status: Unknown

Conditions: Venous Reflux; Chronic Venous Insufficiency; Varicose Veins

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT04339075

2019/2749

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Venablock

Description:

Patients that have undergone Venablock treatment

Treatment:

Other: Questionnaires