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New treatment option for Varicose Veins of Lower Limb
Official title Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins
ClinicalTrials.gov ID: NCT06711120
What this study is testing
- What it's testing
- Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join 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...
- 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;
You likely can't join if
- Thrombosis of the great saphenous or small saphenous vein, or combined deep vein thrombosis, or previous history of deep vein thrombosis or pulmonary...
- 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).
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.