Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU)

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 23, 2022

Primary Completion Date

October 8, 2022

Study Completion Date

January 31, 2023

Conditions
Great Saphenous Vein Insufficiency
Interventions
DEVICE

Sonovein Treatment

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.

Trial Locations (1)

07631

Englewood Health, Englewood

All Listed Sponsors
lead

Englewood Hospital and Medical Center

OTHER