Skip to main content
OpenTrials
Completed

NCT Number: NCT04671641

Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital, Shanghai, Shanghai Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years old, no gender limit.
  • Great saphenous varicose, CEAP grade C2-C6.
  • The diameter of the diseased vein is ≥2mm, ≤15mm.
  • Expected survival period ≥ 6 months.
  • The informed consent form can be signed by the patient or the legal representative.

Exclusion criteria

  • Are pregnant or breastfeeding.
  • Participating in clinical trials of other devices or drugs.
  • Deep vein thrombosis in the affected limb.
  • Uncorrectable coagulation dysfunction and obvious abnormal blood picture, with obvious bleeding tendency (platelets≤30x109/L).
  • Acute thrombosis in the main saphenous vein of the affected limb.
  • The investigator judged that it is not suitable to participate in the clinical trial.

Treatment and study plan

Radiofrequency Ablation

Device

ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients

Primary outcomes

  1. Vascular closure rate at 6 months after the operation

    Time frame: 6 months

    Calculation method: completely closed patients / total cases of subjects in the same group x 100%.

    Definition of complete closure: Complete closure refers to ultrasound follow-up at 6 months after surgery that shows no blood flow in varicose veins.

Secondary outcomes

  1. CEAP

    Time frame: 6 months

    The CEAP is an elaborate scoring system for varicose veins and other disorders from venous insufficiency. It has been developed to determine the severity of the condition for diagnosis and treatment point of view. CEAP stands for:

    Clinical Etiopathological Anatomical Pathophysiological

  2. Technical success rate

    Time frame: 6 months

    The device is delivered in place and withdrawn smoothly, and the target diseased blood vessel is immediately examined by ultrasound without blood flow.

  3. Evaluation of the use of devices

    Time frame: 6 months

    For endovenous radiofrequency closure catheter: evaluation on the degree of device flexibility, crossability, accuracy, usability (subjective evaluation scale: excellent, good and poor) For endovenous radiofrequency closure generator: evaluation on applicability,accuracy of identifying catheter version, stability in the procedure(subjective evaluation: yes or no)

  4. VCSS

    Time frame: 6 months

    Changes from baseline in venous clinical severity score (VCSS) (0-30, higher scores mean a worse outcome) in outpatient services. the VCSS was derived by the American Venous Forum from the CEAP classification and provides means by which clinical outcomes in venous disease can be monitored in time.Compared to the CEAP, VCSS is said to be more responsive to changes in disease severity, thus making it great for progressive rankings. It proved good inter and intra observer reproducibility and is often cited in quality of life assessments

Other outcomes

  1. Rate of serious adverse events within 6 months after surgery

    Time frame: 6 months

  2. Rate of adverse events within 6 months after surgery

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Suzhou Hengruihongyuan Medical Technology Co. LTD

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.