This is a multi-center series assessment with a planned accrual of 70 patients with diagnosed symptomatic primary GSV insufficiency. Patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will receive treatment with Sonovein for the targeted segments of GSV. At follow-up visits at 7 days (1 to 10 days), 3 months (+/- 20 days), 6 months (+/- 25 days), and 12 months (+/- 30 days) changes in veins and flow characteristics will be evaluated by ultrasound, and patient well-being, including pain which will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 12 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
The Sonovein System provides High Intensity Focused Ultrasound (HIFU) ablation of soft tissue. The energy is delivered via an extra-corporeal treatment probe, which includes an imaging system. The high-energy ultrasound waves propagate through the skin and are focused on a portion of the target tissue, generating intense heat and causing local cell apoptosis and progressive tissue volume reduction over the following months in the tissue. The process is then repeated in a stepwise fashion.
Englewood Health
Englewood, New Jersey, United States
Northwell Health
Lake Success, New York, United States
Praxis für Phlebologie
Melk, Austria
Phlebomedica s.r.o
Říčany, Czechia
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein (as measured by Duplex ultrasound)
Time frame: 12 months
Complications
Number of limbs presenting complications and side effects resulting from the GSV intervention
Time frame: 12 months
Reflux-free Rate
Percentage of limbs without reflux in the treated vein (as measured by Duplex ultrasound)
Time frame: 12 months
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Time frame: 12 months
Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.