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Pilot Study: Evaluation of the Safety of the Application of Non-thermal HIFU for Varicose Veins Treatment of the Lower Limbs

Sponsor: VeinSound • ClinicalTrials.gov ID: NCT07878767

Registry updated: 2026-10-16

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Description

EASY-VEIN NT is a pilot, prospective, single-center, non-randomized clinical investigation evaluating the safety and feasibility of the application of non-thermal high-intensity focused ultrasound (NT-HIFU) for the treatment of varicose veins of the lower limbs using the device of Veinsound's company. A total of 15 adult patients, regardless of gender, presenting with superficial venous disease classified as CEAP C2 to C3, will be enrolled in this clinical investigation. All participants will receive a single treatment with the investigational device. The investigational procedure consists of the application of non-thermal high-intensity focused ultrasound (NT-HIFU) along the target refluxing vein under ultrasound guidance. Follow-up visits are scheduled at 8 days, 1 month, and 3 months after treatment to assess safety and preliminary efficacy. An additional early safety visit is performed at 3 days after treatment for the first enrolled participants only. Safety and feasibility will be evaluated through assessment of device-related and procedure-related adverse events, up to 3 months after treatment.

Interventions

Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up (Device)
Treatment using the investigational Veinsound system, an innovative non-thermal high-intensity focused ultrasound device used for the first time in humans.

Eligibility criteria

Inclusion Criteria: * Patient with C2-C3 superficial venous insufficiency (CEAP classification) and a refluxing saphenous vein verified by DUS (reflux \> 0.5 sec) * Great saphenous vein or anterior accessory saphenous vein reflux * Diameter of the saphenous vein lumen ≤ 6 mm * Depth of the vein in relation to the skin surface between 5 mm and 30 mm * Physical condition allowing an outpatient procedure * Patient aged 35 or higher * Willing and able to comply with all study requirements * Signature of informed consent Exclusion Criteria: * Venous lumen diameter \> 6mm * Saphenous Vein depth \> 30 mm or \< 5 mm * Skin alteration in the path of the vein to be treated * Target vein not clearly visible with DUS * Venous malformation * Present or history of deep vein or superficial vein thrombosis * Patients undergoing treatment with anticoagulants or antiplatelet agents * Patients undergoing analgesic therapy * Suffering from a severe comorbid condition (e.g., cancer, progressive hepatitis, heart failure, renal failure, lower limb artery disease, acute infection etc.) * Thrombophilia * Known patent foramen oval * Pregnancy, breastfeeding * Patients taking part in another interventional clinical trial involving an investigation of medicinal products, a medical device or a biological product * Patients under 35 years or over 80 years

Conditions

Superficial Venous Insufficiency, Varicose Veins

Locations

Centrul Medical Sanconfind — Câmpina, Prahova, Romania

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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