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

NCT07445425 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2026-03-03

No results posted yet for this 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

Conditions

  • Varicose Veins of Lower Limb

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07445425 on ClinicalTrials.gov