This is a one-arm, open label, prospective, single-center study. Primary objective To evaluate the feasibility of HIFU for treatment of Great Saphenous Vein using assessments of patient experience and response to treatment. Secondary objective To assess the general safety and ablation rate outcomes following HIFU treatment of GSV
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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 within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues.
Englewood Health
Englewood, New Jersey, United States
Technical Feasibility
Technical feasibility of the procedure in terms of the procedure technical success rate
Time frame: 3 months
Ablation of venous reflux
\- Ablation of venous reflux (as measured by Duplex ultrasound)
Time frame: 3 months
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