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

NCT05193643 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-19

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Englewood Hospital and Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2022-10-08
Completion
2023-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05193643 on ClinicalTrials.gov