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Completed

NCT Number: NCT05193643

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

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

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Key information

Conditions

Great Saphenous Vein Insufficiency

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Englewood Health

Englewood, New Jersey, 07631, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidate for venous procedure with primary GSV insufficiency involving reflux in the segment to be treated
  • CEAP-clinical classification ≥ 2
  • Physical condition allowing ambulation after the procedure.
  • Agree to comply with the Clinical investigation plan and follow-up schedule of the study
  • Targeted tissue reachable for treatment with the device - meaning between 5mm and 24mm below the skin surface.
  • Age over 22 years at the time of enrollment.
  • No acute venous thrombosis.
  • No complete or near complete deep vein post-thrombotic disease.
  • Patient has signed and understood the written informed consent.

Exclusion criteria

  • Patient is pregnant
  • Known allergic reaction to anesthetics to be used.
  • Legally incapacitated or imprisoned patients
  • Patient's vein target not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
  • Patient participating in another clinical trial involving an investigational drug or device.
  • Ankle-brachial index <7 (ABI)
  • Undergoing active anticoagulant therapy within the last 6 months
  • Diameter of the treated anatomical segment below ≤ 2mm

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Treatment and study plan

Sonovein Treatment

Device

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.

Primary outcomes

  1. Technical Feasibility

    Time frame: 3 months

    Technical feasibility of the procedure in terms of the procedure technical success rate

Secondary outcomes

  1. Ablation of venous reflux

    Time frame: 3 months

    • Ablation of venous reflux (as measured by Duplex ultrasound)

Sponsors and collaborators

Lead sponsor

Englewood Hospital and Medical Center

Other

Registry information

Official study title

Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Single Center Prospective Feasibility Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 18, 2022
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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