Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins

Recruiting now · Not applicable

Conditions studied: Varicose Veins of Lower Limb, Venous Insufficiency of Leg, Vascular Disease，Peripheral

In brief

Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.

Key facts

Study ID

NCT06711120

Run by

Chengdu University of Traditional Chinese Medicine

People needed

150

Starts

2024-12-01

Expected to finish

2025-12-01

Last updated by the study team

2024-12-02

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years and ≤90 years;
• Clinical diagnosis of primary varicose veins of the lower extremities, CEAP clinical classification C2-C6, requiring treatment of the great and/or small saphenous vein segments, and at least 1 of the clinical symptoms of swelling, pain, burning sensation, heaviness, easy fatigue, itchy skin, and night cramps;
• Valve insufficiency of the great saphenous vein, small saphenous vein, or transport vein;
• Doppler ultrasound confirmation of a saphenous vein diameter greater than 3 mm and less than 12 mm in the standing position;
• Only one limb per patient was selected for inclusion in the study;
• Patients signed an informed consent form and were willing to co-operate in completing the protocol-specified investigations and follow-up visits.

You may not qualify if…

• Thrombosis of the great saphenous or small saphenous vein, or combined deep vein thrombosis, or previous history of deep vein thrombosis or pulmonary embolism.
• Recurrent varicose veins after previous treatment.
• Severe distortion of the great saphenous vein with anticipated catheter failure.
• Severe lower limb ischaemia (CLI) (ABPI <0.8).
• Known allergy to medications and device materials involved in the study.
• Pre-existing implanted pacemaker, defibrillator, currently on regular anticoagulation therapy (e.g., warfarin, heparin).
• Women who are pregnant or breastfeeding.
• Unable or unwilling to complete the questionnaire.
• Participating in a study of another drug or device.
• Life expectancy <1 year.
• Those undergoing treatment for skin malignancies other than non-melanoma.
• Daily use of narcotic drugs or non-steroidal anti-inflammatory drugs to control pain due to venous disease.
• In the judgement of the investigator, endovenous therapy is not appropriate.

Where it is running

• Hospital of Chengdu University of Traditional Chinese Medicine — Chengdu, China (enrolling)

Full record on ClinicalTrials.gov

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