NCT04534244

Impact of Endovenous Water Vapor Treatment on Quality of Life in Superficial Venous Insufficiency of the Lower Limbs

Management of Tributary Veins in Superficial Venous Insufficiency of the Lower Limbs: Impact of Endovenous Steam Treatment Versus Phlebectomy on Quality of Life

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of superficial chronic venous insufficiency (CVI) of the lower limbs is estimated at 18 million French people. The number of patients operated for varicose veins is around 300,000 per year. Post-operative complications such as venous ulcer, venous thrombosis and varicose vein rupture require a lot of medical care. Varicose veins are responsible for a decrease in quality of life and represents 1 to 2% of total health expenditure. Currently, operating techniques tend towards minimally invasive procedures in order to minimize the surgical trauma, improve patient comfort and reduce the time of postoperative work stoppages. This study aims to compare two surgical techniques for the treatment of superficial chronic venous insufficiency of the lower limbs : phlebectomy, the gold-standard technique, and endovenous steam treatment. Several studies have already been carried out on endovenous steam treatment for saphenous veins but none has been published concerning the tributary veins.The main objective of INVOLVE is to assess the quality of life of patients 1 month after surgery. Clinical improvement and economic impact will also be evaluated.

Conditions

• Venous Insufficiency of Leg

Interventions

Type	Name	Description
DEVICE	VBox Hybrid	Medical device intended to treat permanent venous insufficiency of saphenous veins and tributary veins in patients with superficial venous reflux

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-06-01
• Completion: 2023-10-01
• First posted: 2020-09-01
• Last updated: 2024-09-19