Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07445425

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Staged surgery group

Procedure

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

Procedure

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.

Primary outcomes

  1. The re-intervention rate

    Time frame: 1 week, 3 months and 6 months after surgery

Secondary outcomes

  1. Treatment cost

    Time frame: 6 months after surgery

    According to the statistics of hospital charging system

  2. Success rate of varicose vein closure

    Time frame: 1 week, 3 months and 6 months after surgery

  3. Operation time

    Time frame: During the operation

  4. Number of incisions

    Time frame: During the operation

  5. Tumescent anesthesia solution dosage

    Time frame: During the operation

  6. The amount of intraoperative bleeding

    Time frame: During the operation

  7. AVVQ score

    Time frame: Before surgery, 1 week, 3 months and 6 months after surgery

    The Aberdeen varicose vein questionnaire. The score range is 0-100, and the higher the score, the worse the result.

  8. VAS score

    Time frame: Before surgery, 1 week, 3 months and 6 months after surgery

    Visual analogue scale. The score range is 0-10, and the higher the score, the worse the result.

  9. VCSS score

    Time frame: Before surgery, 1 week, 3 months and 6 months after surgery

    Venous clinical severity score. The score range is 0-30, and the higher the score, the worse the result.

  10. Postoperative complications

    Time frame: 1 week, 3 months and 6 months after surgery

  11. Time to return to regular work

    Time frame: 1 week after surgery

  12. Patient satisfaction

    Time frame: During the operation and 6 months after surgery

    Include two question: "The quality of treatment that you received was good?" "The treatment that you received fulfilled your expectations?"

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

Comparison of Concomitant or Staged Treatment of Tributary Veins for Lower Extremity Varicose Veins: A Multicenter Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

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.

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