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

Launched by CHENGDU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Nov 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments—radiofrequency ablation and microwave ablation—to see which one works better for patients with small saphenous varicose veins. Varicose veins can cause uncomfortable symptoms like swelling, pain, and heaviness in the legs. The trial aims to find out how effective these procedures are in helping patients feel better and improve their quality of life.

To be eligible for this trial, participants need to be between 18 and 90 years old and have a diagnosis of primary varicose veins in their legs. They should be experiencing symptoms like pain or swelling and have a confirmed vein size that meets the study requirements. Only one leg will be treated, and participants must be willing to attend follow-up visits. It's important to note that individuals with certain conditions, such as severe vein issues or those on specific medications, may not qualify for this study. Participants can expect to receive treatment and be monitored for their progress, contributing to research that could help others in the future.

Gender

ALL

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.