NCT05312970

Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)

A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe insights into the benefits of Varithena compared to Endothermal Ablation (ETA) in the treatment of the great saphenous vein.

Detailed description

To collect comparative evidence on patient reported outcomes of Varithena compared to ETA when used to treat the incompetent great saphenous vein (GSV). ETA will include either radiofrequency ablation or endovenous laser ablation according to the site's standard practice. To provide long term (1-year, 2-year, and 3-year) outcomes.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
DRUG	Varithena®	Varithena® (polidocanol injectable foam) 1%
DEVICE	FDA-approved Endothermal Ablation (ETA) systems	FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.

Timeline

• Start date: 2023-02-10
• Primary completion: 2024-04-04
• Completion: 2024-04-04
• First posted: 2022-04-06
• Last updated: 2026-03-20
• Results posted: 2026-03-20

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study