varices varicose veins
Conditions
Interventions
1. Radiofrequency Ablation
RFA will be performed with the patient under local tumescent anesthesia in an
outpatient setting. Venous access is obtained by a puncture with a 19 G needle
under US guid
Sponsors
Dermatologsich Centrum Wetering
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes 1. Obliteration of the GSV and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the GSV. This is measured using US examination. The rates will be compared between RFA and Steam Ablation at 12 and 52 weeks. 2. Venous Clinical Severity Scoring (VCSS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. Treatment safety: a. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. b. Minor complications: ecchymosis, pain and hyperpigmentation. | — |
Countries
Netherlands
Outcome results
None listed