Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

NCT04671641 | Completed

• 1 other identifier: RFS 1.0
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (1)

• Vascular closure rate at 6 months after the operation

  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.

  6 months

Secondary Outcomes (4)

• CEAP

  6 months

• Technical success rate

  6 months

• Evaluation of the use of devices

  6 months

• VCSS

  6 months

Other Outcomes (2)

• Rate of serious adverse events within 6 months after surgery

  6 months

• Rate of adverse events within 6 months after surgery

  6 months

Study Arms (2)

Endovenous Radiofrequency Ablation Closure System

EXPERIMENTAL

Device: radiofrequency ablation

ClosureFast™ Radiofrequency Ablation System

ACTIVE COMPARATOR

Device: radiofrequency ablation

Interventions

radiofrequency ablation DEVICE

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

ClosureFast™ Radiofrequency Ablation System; Endovenous Radiofrequency Ablation Closure System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Hengruihongyuan Medical Technology Co. LTD: lead

Study Sites (5)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

Location

ZheJiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

The Fourth Affiliated Hospital ,Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 322000, China

Location

MeSH Terms

Conditions

Varicose Veins

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: March 24, 2021
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)