First-In-Human Pilot Study: Evaluation of the Safety 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
| Registry | NCT07878767, acronym EASY-VEIN NT |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 15 (Estimated) |
| Sponsor | VeinSound (Industry) |
| Conditions | Superficial Venous Insufficiency, Varicose Veins |
| Interventions | Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up (Device) |
| Dates | start 2026-04-22, primary completion 2026-12-15 (estimated), completion 2026-12-15 (estimated), first posted 2026-10-16, last updated 2026-10-16 |
| Locations | 1 site in Romania |
Related Papers Related Patents Related Grants Related Experts
All trials for Superficial Venous Insufficiency, Varicose Veins All trials of Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| NT-HIFU treatment with Veinsound device | Experimental | Device: Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up | Patients with refluxing superficial venous insufficiency meeting the eligibility criteria and treated with the Veinsound system. |
Sex: All, ages: 35 Years to 80 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Centrul Medical Sanconfind | Câmpina, Prahova | Romania | Recruiting |