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

Zhejiang University logo

Zhejiang University

Status

Not yet enrolling

Conditions

Varicose Veins of Lower Limb

Treatments

Procedure: Concomitant surgery group
Procedure: Staged surgery group

Study type

Interventional

Funder types

Other

Identifiers

NCT07445425
2025-2700-01

Details and patient eligibility

About

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

Enrollment

206 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

206 participants in 2 patient groups, including a placebo group

A
Experimental group
Treatment:
Procedure: Staged surgery group
B
Placebo Comparator group
Treatment:
Procedure: Concomitant surgery group

Trial documents
2

Trial contacts and locations

21

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Central trial contact

Meijia Xu

Data sourced from clinicaltrials.gov

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