A Singapore Venaseal Real World Post-Market Evaluation Study (ASVS)

Singapore Health Services (SingHealth)

Status: Completed

Conditions: Venous Reflux; Chronic Venous Insufficiency; Varicose Veins

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT03893201

2017/2087

Details and patient eligibility

About

The study aims to assess the efficacy of VenaSeal™ Closure System (VCS) 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 ASVS study is to investigate the performance of cyanoacrylate glue closure (CAC) in a real-world post market evaluation setting in which multiple incompetent superficial saphenous truncal veins - namely (great saphenous vein (GSV), short saphenous vein (SSV), anterior accessory saphenous vein (AASV) - will be treated at the same setting, and compression stockings will not be used postoperatively. Unlike previous studies, the inclusion criteria for this study will be liberalized, and veins up to 12mm in diameter will be treated. As such, ASVS will be the first published prospective trial conducted in Asia on a predominantly Asian cohort of patients to report on the performance of CAC for incompetent GSV and non-GSV trunks. This study specifically focuses on the initial technical outcomes, safety, anatomical occlusion and patient experience with CAC applied with broader inclusion of patients than previous trials.

Enrollment: 100 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 21 years old and able to understand the requirements of the study and to provide informed consent
• C2 - C5 symptomatic veins / Chronic Venous Insufficiency
• 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
• Recurrent varicose veins
• Pregnant patients
• Arterial Disease (ABPI<0.8)
• Sepsis
• Patients who are unwilling to participate
• Inability or unwillingness to complete questionnaires
• Adverse reaction to sclerosant or cyanoacrylate
• GSV, SSV or AASV severely tortuous
• 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

Trial design

100 participants in 1 patient group

Venaseal

Description:

Patients that have undergone venaseal

Treatment:

Other: Questionnaires