Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

October 12, 2023

Primary Completion Date

June 11, 2025

Study Completion Date

June 11, 2025

Conditions
Chronic Venous 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. The process is then repeated in a stepwise fashion.

Trial Locations (4)

3390

Praxis für Phlebologie, Melk

11042

Northwell Health, Lake Success

07631

Englewood Health, Englewood

Unknown

Phlebomedica s.r.o, Říčany

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Theraclion

INDUSTRY

NCT05926830 - Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study | Biotech Hunter | Biotech Hunter