Comparative randomized Clinical trial of Radiofrequency Ablation (VNUS )versus Steam Ablation for the treatment of Great Saphenous Veins
Recruiting
- Conditions
- varicesvaricose veins10057165
- Registration Number
- NL-OMON39248
- Lead Sponsor
- Dermatologsich Centrum Wetering
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 260
Inclusion Criteria
• Patients over 18 years old
• No prior treatment of the insufficient GSV
• Insufficieny of the GSV measured with ultrasound imaging, reflux > 0.5 s, and diameter of vein >5 mm.
• Informed consent
Exclusion Criteria
• Acute deep or superficial vein thrombosis
• Agenesis of deep vein system
• Vascular malformation or syndrome
• Post-thrombotic syndrome, occlusive type
• Pregnancy
• Immobility
• Allergy to lidocaine
• Arterial insufficiency
• Use of coumarine anticoagulants
• Mentally unable to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcomes<br /><br>1. Obliteration of the GSV and/ or absence of reflux (>0.5 sec. of retrograde<br /><br>flow over >10cm) along the treated segment of the GSV. This is measured using<br /><br>US examination. The rates will be compared between RFA and Steam Ablation at 12<br /><br>and 52 weeks.<br /><br>2. Venous Clinical Severity Scoring (VCSS). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes<br /><br>1. Treatment safety:<br /><br>a. Major complications: deep and superficial venous thrombosis (embolic<br /><br>events), nerve injury, skin burns, and (sub)cutaneous infections.<br /><br>b. Minor complications: ecchymosis, pain and hyperpigmentation. </p><br>