Endovenous RFA Versus Ligation and Striping for Varicose Veins

NCT04526626 | Unknown FDA Device

• 1 other identifier: HKUSZH201901013
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Radiofrequency ablation; High ligation and striping

Outcome Measures

Primary Outcomes (3)

• Technical success

  Occlusion of the long saphenous vein

  up to 24 months

• Complications

  Deep vein thrombosis, skin burn

  2 weeks after operation

• Recurrence of varicose vein

  Recurrence of varicose vein

  up to 24 months

Study Arms (1)

High ligation and stripping

EXPERIMENTAL

High ligation and stripping of long saphenous vein is the traditional standard procedure for the treatment of varicose veins

Device: Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)

Interventions

Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic) DEVICE

Thermal injury to long saphenous vein

Also known as: ClosureFast, Medtronic

High ligation and stripping

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of long saphenous varicose veins

You may not qualify if:

• Contraindicated to operation due to severe comorbidities

Sponsors & Collaborators

• The University of Hong Kong-Shenzhen Hospital: lead

Study Sites (1)

University of Hong Kong Shenzhen Hospital

Shenzhen, Guangdong, 518053, China

Location

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Hailei Li, M.D, Ph.D

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: August 26, 2020
• Study Start: February 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)