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Retrospective Review of Saphenous Vein Incompetence: Venaseal Versus Endovenous Thermal Ablation — VALUE  

Varicose Veins Clinical Trial

Official title:
Venaseal Versus Ablation With Endothermal Laser or Radiofrequency for Saphenous Vein Incompetence: a Comparison of Utilization of Adjunctive Phlebectomy

Clinical Trial Summary

This study is a retrospective, chart review of treatment of patients with symptomatic varicose veins. Treated limbs must have the Great Saphenous Vein and/or Small Saphenous Vein treated with either cyanoacrylate closure (VenaSeal) or Endothermal Ablation (either Radiofrequency Ablation or Endovenous Laser Ablation).

Clinical Trial Description

This single site, retrospective, comparison study aims to review up to 400 treated limbs with symptomatic varicose veins to compare the need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure in conjunction with either cyanoacrylate closure versus endothermal ablation of incompetent saphenous veins through 6 months of the index procedure. The overall cost of treatment for both groups will be compared.

Some of the secondary aims of this study include:

1. To assess changes in Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class after completion of treatment.

2. To assess changes in revised Venous Clinical Severity Score (rVCSS) and compare the two groups.

3. To assess the need for adjunctive therapies.

4. To record and compare retrospectively the adverse events between the two groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04006184
Study type Observational
Source Lake Washington Vascular
Contact
Status Completed
Phase
Start date June 14, 2019
Completion date August 30, 2019
View Details
See also
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