NCT04526626

Endovenous RFA Versus Ligation and Striping for Varicose Veins

Endovenous Radiofrequency Ablation Versus High Ligation and Striping for Treatment of Varicose Veins: a Prospective Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: The University of Hong Kong-Shenzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. There are few studies comparing RFA and stripping in the treatment of varicose vein. This study was to investigate the outcomes of RFA and stripping for varicose vein. Patients with varicose veins will be prospectively allocated to RFA group and stripping group. Ultrasound follow-up will be performed to assess recanalization of long saphenous vein at 1 month, 3, 6 and 12 months. Recurrence of varicose vein and improvement of symptoms will also be evaluated. The primary endpoints are technical success, complications and recurrence of varicose vein. Secondary endpoints are duration of operation, blood loss, recovery time, venous clinical severity score, and medical cost. The treatment outcomes will be compared between the RFA group and stripping group. RFA is comparable to traditional stripping in the treatment of varicose vein, however, it is associated quick recovery, lower incidence of complications and higher medical cost.

Conditions

• Varicose Veins of Lower Limb

Interventions

Type	Name	Description
DEVICE	Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)	Thermal injury to long saphenous vein

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-08-26
• Last updated: 2020-08-26

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study