Ultrasound-guided treatment for varicose veins
Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve
NA · The Fourth Affiliated Hospital of Zhejiang University School of Medicine · NCT05914740
This study is testing a new way to treat varicose veins by using ultrasound to guide a procedure that helps improve the function of the veins in the legs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine (other) |
| Locations | 1 site (Yiwu, Zhejiang Procince) |
| Trial ID | NCT05914740 on ClinicalTrials.gov |
What this trial studies
This project explores the feasibility of remodeling the venous valves in the lower extremities using ultrasound guidance. Patients diagnosed with primary varicose veins will undergo a preoperative evaluation to assess their condition and design a personalized surgical approach. During the procedure, hyaluronic acid will be injected around the affected valves to enhance their function, with continuous ultrasound monitoring to ensure safety and effectiveness. Postoperative assessments will evaluate the function of the remodeled valves and any complications that may arise.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with clinically diagnosed primary varicose veins and specific ultrasound findings indicating valve insufficiency.
Not a fit: Patients with deep vein valvular insufficiency or those who have previously undergone surgical treatment for the affected blood vessels may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the function of venous valves in patients with varicose veins, potentially reducing symptoms and preventing further complications.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using ultrasound guidance for vascular interventions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80, gender unlimited * CEAP grading was C2-C5 patients * The patient was clinically diagnosed as a primary varicose great saphenous vein of lower extremity, and the ultrasound findings were great saphenous vein valve insufficiency (complete structure, normal shape, enlarged valve ring, Duration of reflux \>0.5s), only unilateral varicose great saphenous vein was treated this time Exclusion Criteria: * Patients with target vessel diameter \< 3mm * The final valve of the great saphenous vein was not clear or lost its normal shape on ultrasound * Patients with deep vein valvular insufficiency * The presence of thrombus or thrombophlebitis in the main trunk of great cryptic skin * Target diseased blood vessel had previously received surgical treatment * Patients with deep vein thrombosis or history of pulmonary distension embolism * Patients with active implants such as pacemakers or ICDs * Patients with severe abnormal liver and kidney function (more than three times the normal value) * Patients with non-primary varicose veins caused by post-deep vein thrombosis syndrome, Cockett syndrome (iliac vein compression syndrome), KT syndrome (venous malformation hypertrophy syndrome \>, arteriovenous sputum, etc * Any serious or uncontrolled systemic disease (including poorly medicated hypertension, diabetes, and diseases with active bleeding signs or severe coagulopathy) * Patients with diseases that may make treatment and evaluation difficult (e.g., malignant arsine tumor, acute infectious diseases, sepsis, systemic intolerability of surgery, life expectancy less than 12 months, etc.) * Pregnant and lactating women, or those who planned to have children during the study period * Patients who have participated in clinical trials of other drugs or medical devices within the last 3 months * Anesthetist and other patients were deemed unsuitable for the study
Where this trial is running
Yiwu, Zhejiang Procince
- The Fourth Affiliated Hospital Zhejiang University School of Medicine — Yiwu, Zhejiang Procince, China (RECRUITING)
Study contacts
- Study coordinator: Yuefeng Zhu, Master's
- Email: zhuyuefeng@126.com
- Phone: 13868101010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Varicose Veins of Lower Limb, Varicose veins in the lower extremities, Ultrasonic guidance, venous valve of Lower limb