Actively Recruiting
Randomized Controlled Study Comparing Radiofrequency and Microwave Ablation for Small Saphenous Vein Varicose Veins
Led by Chengdu University of Traditional Chinese Medicine · Updated on 2024-12-02
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the clinical effectiveness of two minimally invasive treatments, ultrasound-guided radiofrequency ablation and microwave ablation, for primary small saphenous varicose veins, a type of chronic venous insufficiency affecting the lower limbs. Small saphenous varicose veins are less common but more challenging to treat due to their anatomical connection to the popliteal vein and the risk of nerve injury with traditional surgery. The study addresses the need for safer, less invasive options with fewer complications and better recovery. Participants will receive either radiofrequency ablation or microwave ablation, both performed under local anesthesia with ultrasound guidance. The procedure involves injecting anesthetic along the vein, making a small incision near the ankle, and inserting a catheter to deliver energy to close the affected vein. Patients will be monitored for postoperative recovery, including length of hospital stay, time to mobilization, pain scores, and complications. Follow-up with Doppler ultrasound will occur at 2 weeks, 1 month, and 3 months to check for vein closure and recurrence. Quality of life and symptom assessments will be conducted using standardized scoring systems. During the study, participants will undergo several evaluations including clinical symptom assessments, venous ultrasound imaging, and questionnaires on venous disease impact and quality of life. The primary outcome is the vein occlusion rate at 6 months after surgery. Researchers will also track complications and the effectiveness of each treatment over time. The total participation period includes these follow-ups and assessments to ensure safety and monitor long-term treatment success.
CONDITIONS
Brief Title
Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 90 years
- Clinical diagnosis of primary varicose veins of the lower extremities, CEAP clinical classification C2-C6
- Require treatment of great and/or small saphenous vein segments with at least one symptom such as swelling, pain, burning, heaviness, fatigue, itching, or night cramps
- Valve insufficiency of great saphenous vein, small saphenous vein, or transport vein
- Doppler ultrasound showing saphenous vein diameter between 3 mm and 12 mm when standing
- Only one limb per patient included
- Signed informed consent and willingness to complete study procedures and follow-up
You will not qualify if you...
- Thrombosis of great or small saphenous vein or history of deep vein thrombosis or pulmonary embolism
- Recurrent varicose veins after previous treatment
- Severe distortion of great saphenous vein making catheter placement difficult
- Severe lower limb ischemia (ABI <0.8)
- Known allergy to study medications or device materials
- Implanted pacemaker or defibrillator, or on regular anticoagulation therapy
- Pregnant or breastfeeding women
- Unable or unwilling to complete questionnaires
- Participation in another drug or device study
- Life expectancy less than 1 year
- Treatment for skin malignancies other than non-melanoma
- Daily use of narcotic or non-steroidal anti-inflammatory drugs for venous pain
- Investigator’s judgment that endovenous therapy is inappropriate
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo ultrasound-guided radiofrequency or microwave ablation to treat small saphenous varicose veins. Local anesthesia is used during the procedure.
1 treatment visit (in-person)
Duration - 3 months
Participants are followed up with color Doppler ultrasound at 2 weeks, 1 month, and 3 months after treatment to monitor for recurrence and assess treatment effect using clinical scoring and quality of life questionnaires.
3 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, China
Actively Recruiting
Research Team
C
Chunshui He, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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