An interventional study of Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up in Superficial Venous Insufficiency, Varicose Veins, sponsored by VeinSound. Recruiting at 1 site in Romania. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by VeinSound · Not applicable, Interventional, and Treatment
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.
258 studies on the registry are indexed under Varicose Veins; 36 are open to participants now.
This study's planned enrollment of 15 is below the median of 104 across 165 interventional studies indexed under Varicose Veins.
Browse Varicose Veins studies →This is the only study on the registry with VeinSound as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with refluxing superficial venous insufficiency meeting the eligibility criteria and treated with the Veinsound system.
Device: 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.
Per procedure and late adverse events (AE) related to the investigational medical device, up to 3 months after procedure
Assessment by the Data and Safety Monitoring Board (DSMB) of the percentage of patients who experienced at least one AE, defined as: * Skin damage (by clinical examination and collection of photographic images) * Deep vein thrombosis and/or pulmonary embolism (by Duplex ultrasound (DUS)) * Superficial vein thrombosis extension (by DUS) * Phlebitis (by clinical examination) * Peri-venous tissues damage (hematoma) (by DUS) * Paresthesia (by clinical examination) * Any other clinical event
Time frame: 3 months
Acceptability
Evaluation of the patient's pain using the Visual Analog Scale (score ranging from 1 to 10, completed by the patient)
Time frame: Immediate post-treatment (D0) and up to 3 months
Acceptability
Evaluation of the patient satisfaction using a patient satisfaction questionnaire provided by the Sponsor and completed by the patient (6 questions: 1) I found the duration of the treatment acceptable: Strongly agree / Agree / Neutral / Disagree / Strongly disagree 2) I found the procedure comfortable: Strongly agree / Agree / Neutral / Disagree / Strongly disagree 3) During the thermal ablation, I experienced: No sensation / A non-painful sensation (please describe) / Painful sensation 4) Based on this experience, I would be willing to undergo this procedure again if needed : Strongly agree / Agree / Neutral / Disagree / Strongly disagree 5) I would recommend this treatment: Strongly agree / Agree / Neutral / Disagree / Strongly disagree 6) Overall, I am satisfied with the treatment I received: Strongly agree / Agree / Neutral / Disagree / Strongly disagree)
Time frame: Immediate post-treatment (D0) and up to 3 months
Efficacy
Obliteration : No flux or reflux registrable along the treated varicose vein by Duplex Ultrasound - Global Duplex Ultrasound results will be reported according to the Union International of Phlebology classification
Time frame: Each follow-up, Up to 3 months
Efficacy
Diameter reduction : Comparaison of the diameter (milimeters) of the treated varicose vein before and after treatment by Duplex Ultrasound - Global Duplex Ultrasound results will be reported according to the Union International of Phlebology classification
Time frame: Each follow-up, Up to 3 months
Efficacy
Absence of reflux : No reflux registrable into the treated varicose vein by Duplex Ultrasound - Global Duplex Ultrasound results will be reported according to the Union International of Phlebology classification
Time frame: Each follow-up, Up to 3 months
Clinical evaluation of the patient
Clinical evaluation according to the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification (C0 to C6)
Time frame: 3 months
Clinical evaluation of the patient
Venous Clinical Severity Score measurements (0 to 30)
Time frame: 3 months
Plan to share: No — Individual participant data will not be shared (data sharing is not relevant for this study and study data are confidential).
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 81 interventional studies with no phase under Varicose Veins, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.