EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

Chronic Venous Insufficiency Clinical Trial

Official title: EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

Status Completed

Clinical Trial Summary

This is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (RF) energy for ablation of the great saphenous vein (GSV).

Clinical Trial Description

Subjects who meet eligibility criteria will undergo a procedure using the Venclose Radiofrequency (RF) System to treat the great saphenous vein.

The technique involves percutaneous access and insertion of the endovenous sectional radiofrequency (EVSRF™) catheter into the target vein under ultrasound guidance and relies on the use of local anesthesia and thermal energy, from a radiofrequency generator, applied to the target vein. After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.

After the treatment procedure, subjects will be evaluated four (4) times to assess vein recanalization and reflux, and to determine the incidence of adverse events. ;

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

• NCT number: NCT04236245
• Study type: Interventional
• Source: Venclose, Inc.
• Status: Completed
• Phase: N/A
• Start date: May 11, 2020
• Completion date: August 2, 2021