NCT04236245

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Venclose, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.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.

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	Venclose RF System	Treatment of great saphenous vein (GSV) using Venclose RF System

Timeline

• Start date: 2020-05-11
• Primary completion: 2021-08-02
• Completion: 2021-08-02
• First posted: 2020-01-22
• Last updated: 2022-04-04
• Results posted: 2022-03-10

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study