Comparing radiofrequency and microwave treatments for small varicose veins

Randomized Controlled Study of Radio Frequency and Microwave of the Small Saphenous Vein

This study is testing whether ultrasound-guided radiofrequency or microwave treatments work better for people with small varicose veins.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Chengdu University of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Chengdu)
• Trial ID: NCT06711120 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of ultrasound-guided radiofrequency ablation versus microwave ablation for treating small saphenous varicose veins. Chronic venous insufficiency is a prevalent condition, and while small saphenous varicose veins are less common, they pose unique treatment challenges. The study aims to evaluate the clinical outcomes of these two minimally invasive techniques, which may offer advantages over traditional surgical methods. Participants will be monitored for symptoms and complications following their respective treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with primary varicose veins of the lower extremities requiring treatment.

Not a fit: Patients with a history of thrombosis or those with recurrent varicose veins may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a safer and more effective treatment option for small saphenous varicose veins.

How similar studies have performed: Previous studies have shown promising results for both radiofrequency and microwave ablation techniques in treating varicose veins, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Chengdu

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

Study contacts

• Study coordinator: Chunshui He, Doctor

Conditions Varicose Veins of Lower Limb; Venous Insufficiency of Leg; Vascular Disease，Peripheral; varicose veins of the small saphenous veins; radiofrequency ablation; microwave ablation