Endovenous RFA Versus Ligation and Striping for Varicose Veins

Varicose Veins of Lower Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04526626
• Other study ID #: HKUSZH201901013
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2020
• Source: The University of Hong Kong-Shenzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of long saphenous varicose veins

Exclusion Criteria:

• Contraindicated to operation due to severe comorbidities

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Lower Limb

Intervention

Device:
• Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)
Thermal injury to long saphenous vein

Locations

Country	Name	City	State
China	University of Hong Kong Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong-Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Occlusion of the long saphenous vein	up to 24 months
Primary	Complications	Deep vein thrombosis, skin burn	2 weeks after operation
Primary	Recurrence of varicose vein	Recurrence of varicose vein	up to 24 months