NCT03893201

A Singapore Venaseal Real World Post-Market Evaluation Study

Multi-Centre Registry to Investigate the Efficacy and Safety of Venaseal Endovenous Ablation for Varicose Veins in Singapore

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Varicose Veins
• Venous Reflux
• Chronic Venous Insufficiency

Interventions

Type	Name	Description
OTHER	Questionnaires	Questionnaires to assess quality of life

Timeline

• Start date: 2018-04-11
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2019-03-28
• Last updated: 2020-03-18

Locations

2 sites across 1 country: Singapore