Varicose veins of the lower extremities
Conditions
Interventions
Experimental Group:Focused Ultrasound Non-Invasive Vein Occlusion System
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18~80 years old (inclusive), regardless of gender; 2.The clinical diagnosis is unilateral/bilateral varicose veins of great saphenous veins of lower limbs, and only one side is treated in this treatment; 3.Patients with CEAP grade C2-C6; 4.Doppler ultrasound confirmed that the diameter of the target vein was >=3mm and <= 15 mm; 5.Patients who voluntarily participate in the trial, understand all the risks and benefits stated in the informed consent document and sign the written informed consent form;
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women, or those planning to have a family during the study period/who are unable to secure effective contraception; 2. The ablated superficial veins were not suitable for treatment, including previous surgical treatment; Secondary varicose veins, such as venous thrombosis syndrome, Cockett syndrome, KT syndrome, arteriovenous fistula, etc. Superficial venous thrombosis and thrombophlebitis of the lower extremities; 3. Peripheral artery disease (ABI225 umol/L); 7. Coagulation dysfunction or obvious bleeding tendency (platelet count <=30X10%L); 8. Participated in other clinical trials within three months; 9. Malignant tumor, survival time <1 year; 10. There were unavoidable hypertrophic scars on the surface of the ablated segmental vessels. 11. Other circumstances considered by the investigator to be inappropriate for participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular closure of the treatment segment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to return to work;Pain;Clinical-etiology-anatomy-pathophysiology venous classification system;Quality of life;Clinical effectiveness;Subject satisfaction evaluation;Time to return to activity;Vascular closure of the treatment segment;Venous clinical severity score; | — |
Countries
China
Contacts
Public ContactYuefeng Zhu
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed