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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
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
35 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-04-22
Completion Date
2026-12-15
Last Updated
2026-10-16
Healthy Volunteers
No
Interventions
Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up
Treatment using the investigational Veinsound system, an innovative non-thermal high-intensity focused ultrasound device used for the first time in humans.
Locations (1)
Centrul Medical Sanconfind
Câmpina, Prahova, Romania