๐ฌIn plain words
What the trial is, and whether it could suit you
Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Age โฅ18 years and โค90 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.