NCT04671641

Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of the endovenous radiofrequency ablation closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the treatment of varicose veins.

Detailed description

In this prospective, multi-center, randomized controlled study, 176 patients who were diagnosed with varicose veins and met the inclusion criteria without any exclusion criteria were randomly divided into the experimental group (Hongyuan Endovenous Radiofrequency Ablation Closure System)and control group (Medtronic's ClosureFast™ Radiofrequency Ablation System) at 1:1. The effectiveness of the product was evaluated by the vascular closure rate at 6 months after the operation, and the safety of the product was evaluated by the incidence of adverse events and serious adverse events within 6 months after the operation.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
DEVICE	radiofrequency ablation	ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients

Timeline

• Start date: 2021-03-24
• Primary completion: 2022-01-01
• Completion: 2022-07-01
• First posted: 2020-12-17
• Last updated: 2025-06-25

Locations

5 sites across 1 country: China