Superficial Venous Insufficiency, Varicose VeinsEASY-VEIN NTNCT07878767
Pilot Study: Evaluation of the Safety of the Application of Non-thermal HIFU for Varicose Veins Treatment of the Lower Limbs
A study testing Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up in people with Superficial Venous Insufficiency, Varicose Veins, run by VeinSound at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Superficial Venous Insufficiency, Varicose Veins
- What is being tested?
- Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteRomania
- Study dates
- 22 Apr 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Centrul Medical Sanconfind
Câmpina, Prahova, 107425
Zoltan Galajda, +40755972042, zgalajda@gmail.com
About this study
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
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.
Read more
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.
- Being tested
- Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up
- Keywords
- Non-thermal HIFU, varicose vein, Veinsound
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-upDevice
Treatment using the investigational Veinsound system, an innovative non-thermal high-intensity focused ultrasound device used for the first time in humans.
| Study group | Role | What they receive |
|---|---|---|
| NT-HIFU treatment with Veinsound device | Experimental | Patients with refluxing superficial venous insufficiency meeting the eligibility criteria and treated with the Veinsound system. Receives: Device: Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (7)
Acceptability
Evaluation of the patient's pain using the Visual Analog Scale (score ranging from 1 to 10, completed by the patient)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 3 months
Clinical evaluation of the patient
Venous Clinical Severity Score measurements (0 to 30)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start22 Apr 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Venous Insufficiency, Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VeinSound
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878767
- Sponsor's protocol ID
- PLN_CA_018
- Acronym
- EASY-VEIN NT
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared (data sharing is not relevant for this study and study data are confidential).
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07878767
- Acronym / sponsor ID
- EASY-VEIN NT / PLN_CA_018
- Keywords
- Non-thermal HIFU, varicose vein, Veinsound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- VeinSoundIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NT-HIFU treatment with Veinsound device | Experimental | Device: Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-upPatients with refluxing superficial venous insufficiency meeting the eligibility criteria and treated with the Veinsound system. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-upTreatment using the investigational Veinsound system, an innovative non-thermal high-intensity focused ultrasound device used for the first time in humans. | Device | NT-HIFU treatment with Veinsound device |
Primary outcome
Per procedure and late adverse events (AE) related to the investigational medical device, up to 3 months after procedure
Time frame: 3 months
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
7 secondary outcomes
Acceptability
Time frame: Immediate post-treatment (D0) and up to 3 months
Acceptability
Time frame: Immediate post-treatment (D0) and up to 3 months
Efficacy
Time frame: Each follow-up, Up to 3 months
Efficacy
Time frame: Each follow-up, Up to 3 months
Efficacy
Time frame: Each follow-up, Up to 3 months
Clinical evaluation of the patient
Time frame: 3 months
Clinical evaluation of the patient
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared (data sharing is not relevant for this study and study data are confidential).
Related trials for Superficial Venous Insufficiency, Varicose Veins
Active, not recruiting
Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
Deep Vein Thrombosis, Venous Stasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-thermal HIFU application along the saphenous vein of one leg / 3-month follow-up in people with Superficial Venous Insufficiency, Varicose Veins, run by VeinSound at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Pichot, Medical Director of Veinsound (+33684978170, olivierp@veinsound.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per procedure and late adverse events (AE) related to the investigational medical device, up to 3 months after procedure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.