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NCT Number: NCT04280679

Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU

This is a one-arm, open label, prospective, single center study to evaluate clinical standardization with Theraclion's Sonovein 2 HIFU device.

The original Sonovein device was tested in a clinical trial in 50 subjects and received CE Mark. That device has been updated yielding the current version of Sonovein 2. Based on the technical similarities between both devices in term of design, performance and principle of operation, the clinical data for Sonovein is sufficient to assure conformity of the Sonovein 2 with the respected essential requirements. At the same time, the compagny wishes to pursue the standardisation of the clinical practice with the second generation device and is, therefore, conducting this limited trial in 20 evaluable cases (from the planned 22 patients to be included). A "case" is defined as procedure conducted on a distinct vein.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Vascular Diseases Veins Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karl Landsteiner Institut für funktionelle Phlebochirurgie

Melk, 3390, Austria

About this study

The Sonovein 2 system provides high intensity focused ultrasound (HIFU) abaltion of soft tissue. The energy is delievered 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 stepwize fashion to destroy the targeted tissues. The Sonovein 2 system is comprised of several components, including the console, treatment arm containing the visualization and treatment unit (VTU), a computer with touchscreen user interface. In addition, the Sonovein 2 system is intended to be used in conjunction with a disposable cooling and coupling system known as ePack.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Candidate for venous procedure involving lower limb superficial insufficiency involving reflux in the segment to be treated
  • Physical condition allowing ambulation after the procedure
  • Availability of the patient for all the follow-up visits
  • Targeted tissue reachable for treatment with the device-meaning between 5mm and 26mm below the skin surface
  • Age over 18 years of age at the time of enrollment
  • No acute venous thrombosis
  • No complete, or near complete deep vein thrombosis
  • Patient has signed a written informed consent
  • Targeted structure sonographically visible

Exclusion criteria

  • Patient is pregnant or nursing
  • Known allergic reaction to anesthetic to be used
  • Legally incapacitated or imprisoned patients
  • Patient's vein target not clearly visible on the ultrasound images (B mode) at the inclusion visit
  • Patient participating in another clinical trial involving an investigational drug, device or biologic

Treatment and study plan

Sonovein 2

Device

Patient are treated with the HIFU device and the pysician is doing a compressive bandage

Primary outcomes

  1. Reduction of venous reflux

    Time frame: 3 months

    As measured by ultrasound

Secondary outcomes

  1. Emergent Adverse Events

    Time frame: 3 months

    Measure of AEs and SAEs recorded in AE form at each visit

  2. Measurement of the need to use tumescence anesthesia during the procedure

    Time frame: 3 months

    Evaluated dichotomously present/absent

  3. Measurement of the need to use adjunctive procedure for treating the reflux

    Time frame: 3 months

    Evaluated dichotomously present/absent

Sponsors and collaborators

Lead sponsor

Theraclion

Industry

Registry information

Official study title

Minimally Invasive Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein 2: a Single Center Prospective Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2020
Registry last updated
Oct 6, 2020

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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