🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07445425
Starting soon Not applicable

Comparison of Radiofrequency Ablation With Concomitant or Staged Treatment for Tributary Varicose Veins

NCT07445425 · tracked via the Priya Life Science China tracker
Sponsor
Sir Run Run Shaw Hospital
Phase
Not applicable
Started
2026-03
Last updated
2026-03-03

Condition(s) studied

Varicose Veins of Lower Limb

Investigational drug(s) / intervention(s)

Staged surgery groupConcomitant surgery group

Staged surgery group: The patient is placed in the supine position, and then a DUS examination of the GSV in the affected limbs will be performed. At the appropriate site, local anesthesia will be performed, and the ultrasound-guided Seldinger technique will be used to puncture the main trunk of the GSV 10cm above and below the knee joint. When the needle puncture is successful, we will insert the guidewire, and a 7F vascular sheath (Terumo) will be inserted along the guidewire. Then, we will insert the radiofrequency catheter and advanced the tip to approximately 2 cm at the junction of the saphenofemoral vein, where it will be left in place. Under ultrasound guidance, the needle will be tightly attached to the GSV sheath, and an anesthetic solution will be injected to treat the swelling until the junction of the saphenofemoral vein will be reached. Then, we will secure the tip of the radiofrequency catheter and switch on the radiofrequency generator and ablated the primary trunk of the GSV in segments.

Concomitant surgery group: While the experimental group receives ablation alone, the control group received 1% polidocanol foam sclerosant injection and/or point excision treatment for the pre-marked calf segment branches of the GSV after ablation treatment. Both groups will wear elastic bandages for 24 hours postoperatively, followed by thigh-length class II compression stockings for 1 week after bandage removal.

Study summary

The purpose of this clinical trial is to know which is better to treat the branch vein at the same time or in stages during radiofrequency ablation. The main questions it aims to answer are:

Does the patient who did not treat the branch vein in the first stage of operation need to intervene again? Are there any differences in patients' indexes between the two surgical strategies?

Participants will:

Radiofrequency ablation with or without foam sclerosing agent therapy One week, three months and six months after operation, go to the clinic for a reexamination.

Record their symptoms

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: aged between 18 and 80 years; primary unilateral lower limb GSV varicose; hemodynamic classification I and III involvement in tributary veins, tributary veins originating within 15 cm inferior to the knee joint; clinical grade C2-C4; primary trunk diameter of GSV in thigh segment≥3mm to ≤ 15 mm; agree to participate in this study and voluntarily sign an informed consent form. Exclusion Criteria: Body Mass Index (BMI) ≥35kg/m2; severe tortuosity or tight adherence of the trunk of the GSV to the skin in the thigh; history of previous varicose vein surgery on the ipsilateral lower limb (investigator allows to be controlled); previous deep vein thrombosis and/or calf muscle venous thrombosis; uncorrectable coagulation disorders or significant blood abnormalities (platelets≤30×109/L); allergy to lidocaine or sclerosing agents; ankle-brachial index (ABI) \<0.6 and/or absolute ankle pressure \<60mmHg; pregnancy or lactation, or intend to have a child in the next year; participation in other clinical trials; anterior saphenous vein start diameter\>3.5mm; any other patients investigator considers improper to participate in this study.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui
Peking University International Hospital Beijing Beijing Municipality
Peking University Third Hospital Beijing Beijing Municipality
Guangxi Zhuang Autonomous Region People's Hospital Nanning Guangxi
The First Affiliated Hospital of Guangxi University of Chinese Medicine Nanning Guangxi
Hainan Provincial Hospital of Traditional Chinese Medicine Haikou Hainan
Zhengzhou Central Hospital Zhengzhou Henan
Zhoukou Central Hospital Zhoukou Henan
The First People's Hospital of Chenzhou Chenzhou Hunan
Huai'an First People's Hospital Huai'an Jiangsu
Jiangsu Province Hospital of Traditional Chinese Medicine Nanjing Jiangsu
The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi
The First Affiliated Hospital of Dalian Medical University Dalian Liaoning
The First Affiliated Hospital of China Medical University Shenyang Liaoning
Dezhou People's Hospital Dezhou Shandong
Yantai Yuhuangding Hospital Yantai Shandong
Zibo First Hospital Zibo Shandong
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
Hangzhou Third People's Hospital Hangzhou Zhejiang
The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
Affiliated Hospital of Shaoxing University Shaoxing Zhejiang

More Sir Run Run Shaw Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07445425 on ClinicalTrials.gov ↗ ← All trials in China